# Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2019-27394

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** December 30, 2019
- **Citation:** 84 FR 71794

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892
[Docket Nos. FDA-2017-N-1129 and FDA-2017-N-1610]
Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final amendment; final order.

SUMMARY:

The Food and Drug Administration (FDA, Agency, or we) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21st Century Cures Act (Cures Act). Although each classification regulation for each such type of device shall be deemed amended to incorporate such exemption, we are publishing this final order to amend the codified language for each listed class I and class II device's classification regulation to reflect the final determinations. FDA's action decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations.

DATES:

This order is effective December 30, 2019.

FOR FURTHER INFORMATION CONTACT:

Karen Fikes, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5502, Silver Spring, MD 20993, 301-796-9603, email:
karen.fikes@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The Cures Act (Pub. L. 114-255) was signed into law on December 13, 2016. Under the Cures Act, section 3054 amended section 510(l) and (m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(l) and (m)). As amended, section 510(l)(2) of the FD&C Act requires FDA to identify through publication in the
Federal Register
, any type of class I device that the Agency determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness.

FDA shall publish this determination within 120 days of the date of enactment of the Cures Act and at least once every 5 years thereafter, as FDA determines appropriate. Further, section 510(l)(2) provides that upon the date of publication of the Agency's determination in the
Federal Register
, a 510(k) will no longer be required for these devices and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.

As amended, section 510(m)(1)(A) of the FD&C Act provides that, within 90 days after enactment of the Cures Act and at least once every 5 years thereafter, FDA shall publish in the
Federal Register
a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. This notice shall provide at least a 60-day comment period. Within 210 days of enactment of the Cures Act, FDA shall publish in the
Federal Register
a list representing its final determination regarding exemption of devices that were contained in the proposed list published under 510(m)(1)(A) of the FD&C Act. Further, section 510(m)(3) of the FD&C Act provides that upon the date of publication of the final list in the
Federal Register
, a 510(k) will no longer be required for these devices and the classification regulation applicable to each such device shall be deemed amended to incorporate such exemption.

In the
Federal Register
of April 13, 2017 (82 FR 17841), in accordance with the amendments to 510(l)(2), FDA issued a notice of final determination to exempt a list of class I devices from premarket notification requirements under section 510(k) of the FD&C Act, subject to certain limitations. In the
Federal Register
of March 14, 2017 (82 FR 13609), in accordance with the amendments to 510(m)(1)(A), FDA issued a notice proposing to exempt a list of class II devices from premarket notification requirements under section 510(k) of the FD&C Act, subject to certain limitations. After a 60-day comment period, in the
Federal Register
of July 11, 2017 (82 FR 31976), FDA issued a notice of final determination to exempt class II devices provided in the proposed list. Through this action, FDA is now amending the codified language for each listed classification regulation to reflect final determinations for these class I and class II exemptions.
1

1
FDA notes that the “ACTION” caption for this final order is styled as “Final amendment; final order,” rather than “Final order.” Beginning in December 2019, this editorial change was made to indicate that the document “amends” the Code of Federal Regulations. The change was made in accordance with the Office of Federal Register's (OFR) interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook.

Following publication of the notices, FDA determined that it is unnecessary to update three classification regulations (21 CFR 872.4565, 21 CFR 878.4014, and 21 CFR 880.6320) included in the class I notice, 82 FR 17841. Five product codes corresponding to these three classification regulations (EGI and EIB (21 CFR 872.4565), OVR (21 CFR 878.4014), KZF and PEQ (21 CFR 880.6320)) were identified for exemption in 82 FR 17841; however, the corresponding classification regulations were already class I, exempt from premarket notification procedures in subpart E of part 807 (21 CFR part 807, subpart E) subject to the limitations in the corresponding “.9” regulations (
i.e.,
21 CFR 872.9, 21 CFR 878.9 or 21 CFR 880.9); and, therefore, no revisions to the codified are necessary. Additionally, we determined that it is unnecessary to update 21 CFR 876.5820 included in the class II notice, 82 FR 13609. The product code within this classification regulation (FKI) was identified for exemption in 82 FR 13609. However, this device type is specifically identified within the class I paragraph of this classification regulation (21 CFR 876.5820(b)(2)) and already exempt from premarket notification procedures in subpart E of part 807 subject to the limitations in 21 CFR 876.9. Therefore, no revisions to the codified are necessary.

We are also making a revision to correct a misidentified classification regulation in 82 FR 31976. The notice incorrectly listed the classification regulation 21 CFR 868.1400 “Carbon dioxide gas analyzer” as corresponding with product code LLK; however, the correct classification regulation associated with product code LLK is 21 CFR 880.5780 “Medical Support Stocking”. Therefore, 21 CFR 868.1400 remains unchanged, and 21 CFR 880.5780(a)(2) is revised to reflect the exemption.

We are revising the name of one classification regulation, currently entitled “Urological clamp for males”, in response to FDA's exemption in 82 FR 17841. Part 876.5160 is currently entitled “Urological clamp for males,” which was previously exempt from premarket notification procedures “. . . Except when intended for internal use or use on females . . .”. In 82 FR 17841, we exempted product code MNG, “External Urethral Occluder, Urinary Incontinence-Control, Female” and removed the current limitation language regarding “use on females.” Therefore, FDA is revising the name of the classification regulation to read “Urological clamp” to ensure clarity.

II. Criteria for Exemption

As amended by the Cures Act, section 510(l) now has two provisions, 510(l)(1) and (2). Under 510(1)(1), a class I device is exempt from the premarket notification requirements under section 510(k) of the FD&C Act, unless the device is intended for a use which is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury. Based on these criteria, FDA evaluated all class I devices to determine which device types should be exempt from premarket notification requirements.

For class II devices, there are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998,
Federal Register
notice (63 FR 3142) and subsequently in the guidance we issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions From Premarket Notification, Guidance for Industry and CDRH Staff ”.
2

2
Available at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff.

III. Limitations on Exemptions

Although FDA exempted the types of class I and class II devices from the premarket notification requirements under section 510(k) of the FD&C Act in accordance with the provisions under 510(l) and (m), an exemption from the requirement of premarket notification does not mean the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.

In addition to being subject to the general limitations to the exemptions found in 21 CFR 862.9 to 892.9, FDA has also partially limited some exemptions from premarket notification requirements to specific devices within

the listed device type. In such situations where a partial exemption limitation has been identified, FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices.

IV. Analysis of Environmental Impact

The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

V. Paperwork Reduction Act of 1995

This final order refers to previously approved FDA collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073.

List of Subjects

21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and 890
Medical devices.

21 CFR Part 864
Blood, Medical devices, Packaging and Containers.

21 CFR Part 866
Biologics, Laboratories, Medical devices.

21 CFR Part 886
Medical devices, Ophthalmic goods and services.

21 CFR Part 892
Medical devices, Radiation protection, X-rays.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 are amended as follow:

PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

1. The authority citation for part 862 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l,
371.

2. In § 862.1020, revise paragraph (b) to read as follows:

§ 862.1020
Acid phosphatase (total or prostatic) test system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

3. In § 862.1090, revise paragraph (b) to read as follows:

§ 862.1090
Angiotensin converting enzyme (A.C.E.) test system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

4. In § 862.1100, revise paragraph (b) to read as follows:

§ 862.1100
Aspartate amino transferase (AST/SGOT) test system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

5. In § 862.1150, revise paragraph (b) to read as follows:

§ 862.1150
Calibrator.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

6. In § 862.1345, revise paragraph (b) to read as follows:

§ 862.1345
Glucose test system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

7. In § 862.1350, revise paragraph (b) introductory text to read as follows:

§ 862.1350
Continuous glucose monitor secondary display.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special controls for this device are:

8. In § 862.1410, revise paragraph (b) to read as follows:

§ 862.1410
Iron (non-heme) test system.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

9. In § 862.1415, revise paragraph (b) to read as follows:

§ 862.1415
Iron-binding capacity test system.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

10. In § 862.1445, revise paragraph (b) to read as follows:

§ 862.1445
Lactate dehydrogenase isoenzymes test system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

11. In § 862.1509, revise paragraph (b) to read as follows:

§ 862.1509
Methylmalonic acid (nonquantitative) test system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

12. In § 862.1580, revise paragraph (b) to read as follows:

§ 862.1580
Phosphorous (inorganic) test system.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

13. In § 862.1660, revise paragraph (b) to read as follows:

§ 862.1660
Quality control material (assayed and unassayed).

(b)
Classification.
Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are

exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

14. In § 862.1685, revise paragraph (b) as follows:

§ 862.1685
Thyroxine-binding globulin test system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

15. In § 862.1700, revise paragraph (b) as follows:

§ 862.1700
Total thyroxine test system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

16. In § 862.1775, revise paragraph (b) to read as follows:

§ 862.1775
Uric acid test system.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

17. In § 862.2265, revise paragraph (b) introductory text to read as follows:

§ 862.2265
High throughput genomic sequence analyzer for clinical use.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special controls for this device are:

18. In § 862.2570, revise paragraph (b) to read as follows:

§ 862.2570
Instrumentation for clinical multiplex test systems.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.

19. In § 862.3050, revise paragraph (b) to read as follows:

§ 862.3050
Breath-alcohol test system.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

20. In § 862.3100, revise paragraph (b) to read as follows:

§ 862.3100
Amphetamine test system.

(b)
Classification.
Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

21. In § 862.3150, revise paragraph (b) to read as follows:

§ 862.3150
Barbiturate test system.

(b)
Classification.
Class II (special controls). A barbiturate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

22. In § 862.3170, revise paragraph (b) to read as follows:

§ 862.3170
Benzodiazepine test system.

(b)
Classification.
Class II (special controls). A benzodiazepine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

23. In § 862.3200, revise paragraph (b) to read as follows:

§ 862.3200
Clinical toxicology calibrator.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

24. In § 862.3220, revise paragraph (b) to read as follows:

§ 862.3220
Carbon monoxide test system.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

25. In § 862.3240, revise paragraph (b) to read as follows:

§ 862.3240
Cholinesterase test system.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

26. In § 862.3250, revise paragraph (b) to read as follows:

§ 862.3250
Cocaine and cocaine metabolite test system.

(b)
Classification.
Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,

programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

27. In § 862.3270, revise paragraph (b) to read as follows:

§ 862.3270
Codeine test system.

(b)
Classification.
Class II (special controls). A codeine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

28. In § 862.3280, revise paragraph (b) to read as follows:

§ 862.3280
Clinical toxicology control material.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

29. In § 862.3580, revise paragraph (b) to read as follows:

§ 862.3580
Lysergic acid diethylamide (LSD) test system.

(b)
Classification.
Class II (special controls). A lysergic acid diethylamide (LSD) test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

30. In § 862.3610, revise paragraph (b) to read as follows:

§ 862.3610
Methamphetamine test system.

(b)
Classification.
Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

31. In § 862.3620, revise paragraph (b) to read as follows:

§ 862.3620
Methadone test system.

(b)
Classification.
Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

32. In § 862.3630, revise paragraph (b) to read as follows:

§ 862.3630
Methaqualone test system.

(b)
Classification.
Class II (special controls). A methaqualone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

33. In § 862.3640, revise paragraph (b) to read as follows:

§ 862.3640
Morphine test system.

(b)
Classification.
Class II (special controls). A morphine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

34. In § 862.3650, revise paragraph (b) to read as follows:

§ 862.3650
Opiate test system.

(b)
Classification.
Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

35. In § 862.3700, revise paragraph (b) to read as follows:

§ 862.3700
Propoxyphene test system.

(b)
Classification.
Class II (special controls). A propoxyphene test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

36. In § 862.3870, revise paragraph (b) to read as follows:

§ 862.3870
Cannabinoid test system.

(b)
Classification.
Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

37. In § 862.3910, revise paragraph (b) to read as follows:

§ 862.3910
Tricyclic antidepressant drugs test system.

(b)
Classification.
Class II (special controls). A tricyclic antidepressant drugs test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (
e.g.,
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

PART 864—HEMATOLOGY AND PATHOLOGY DEVICES

38. The authority citation for part 864 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l,
371.

39. In § 864.5400, revise paragraph (b) to read as follows:

§ 864.5400
Coagulation instrument.

(b)
Classification.
Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

40. In § 864.5425, revise paragraph (b) to read as follows:

§ 864.5425
Multipurpose system for in vitro coagulation studies.

(b)
Classification.
Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

41. In § 864.6550, revise paragraph (b) to read as follows:

§ 864.6550
Occult blood test.

(b)
Classification.
Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

42. In § 864.7040, revise paragraph (b) to read as follows:

§ 864.7040
Adenosine triphosphate release assay.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

43. In § 864.7275, revise paragraph (b) to read as follows:

§ 864.7275
Euglobulin lysis time tests.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

44. In § 864.7300, revise paragraph (b) to read as follows:

§ 864.7300
Fibrin monomer paracoagulation test.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. The special control for this device is FDA's “In Vitro Diagnostic Fibrin Monomer Paracoagulation Test.” See § 864.1(d) for information on obtaining this document.

45. In § 864.7340, revise paragraph (b) to read as follows:

§ 864.7340
Fibrinogen determination system.

(b)
Classification.
Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

46. In § 864.7375, revise paragraph (b) to read as follows:

§ 864.7375
Glutathione reductase assay.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

47. In § 864.7415, revise paragraph (b) to read as follows:

§ 864.7415
Abnormal hemoglobin assay.

(b)
Classification.
Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

48. In § 864.7455, revise paragraph (b) to read as follows:

§ 864.7455
Fetal hemoglobin assay.

(b)
Classification.
Class II (special controls). A fetal hemoglobin stain intended for use with a fetal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

49. In § 864.7500, revise paragraph (b) to read as follows:

§ 864.7500
Whole blood hemoglobin assays.

(b)
Classification.
Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

50. In § 864.7720, revise paragraph (b) to read as follows:

§ 864.7720
Prothrombin consumption test.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

51. In § 864.7735, revise paragraph (b) to read as follows:

§ 864.7735
Prothrombin-proconvertin test and thrombotest.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

52. In § 864.8150, revise paragraph (b) to read as follows:

§ 864.8150
Calibrator for cell indices.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

53. In § 864.8165, revise paragraph (b) to read as follows:

§ 864.8165
Calibrator for hemoglobin or hematocrit measurement.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

54. In § 864.8175, revise paragraph (b) to read as follows:

§ 864.8175
Calibrator for platelet counting.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

55. In § 864.8185, revise paragraph (b) to read as follows:

§ 864.8185
Calibrator for red cell and white cell counting.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

56. In § 864.8625, revise paragraph (b) to read as follows:

§ 864.8625
Hematology quality control mixture.

(b)
Classification.
Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

57. In § 864.9400, revise paragraph (b) to read as follows:

§ 864.9400
Stabilized enzyme solution.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES

58. The authority citation for part 866 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l,
371.

59. In § 866.2900, revise paragraph (b) to read as follows:

§ 866.2900
Microbiological specimen collection and transport device.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

60. In § 866.3395, revise paragraph (b) to read as follows:

§ 866.3395
Norovirus serological reagents.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Norovirus Serological Reagents.” See § 866.1(e) for the availability of this guidance document.

61. In § 866.5210, revise paragraph (b) to read as follows:

§ 866.5210
Ceruloplasmin immunological test system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

62. In § 866.5470, revise paragraph (b) to read as follows:

§ 866.5470
Hemoglobin immunological test system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

63. In § 866.5620, revise paragraph (b) to read as follows:

§ 866.5620

Alpha
-2-macroglobulin immunological test system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

64. In § 866.5630, revise paragraph (b) to read as follows:

§ 866.5630

Beta
-2-microglobulin immunological test system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

65. In § 866.5750, revise paragraph (b) to read as follows:

§ 866.5750
Radioallergosorbent (RAST) immunological test system.

(b)
Classification.
Class II (special controls). The device, when intended to detect any of the allergens included in Table 1 in this paragraph, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Table 1—Class II Exempt Allergens Under § 866.5750—Radioallergosorbent (RAST) Immunological Test Systems

Allergen code
Allergen product

Source
(taxonomical name)

Grass Pollens

g1
Sweet vernal grass

Anthoxanthum odoratum.

g3
Cocksfoot grass, Orchard grass

Dactylis glomerata.

g4
Meadow fescue

Festuca elatior.

g5
Rye-grass (perennial rye grass)

Lolium perenne.

g7
Common reed (common reed grass)

Phragmites communis.

g8
Meadow grass, Kentucky blue (June grass)

Poa pratensis.

g9
Redtop, Bentgrass

Agrostis stolonifera
,
Agrostis gigantea
(
Agrostis alba
).

g11
Brome grass

Bromus inermis.

g12
Cultivated rye (cultivated rye grass)

Secale cereale.

g13
Velvet grass

Holcus lanatus.

g14
Cultivated oat (cultivated oat grass)

Avena sativa.

g15
Cultivated wheat (cultivated wheat grass)

Triticum aestivum
(
Triticum
spp.).

g16
Meadow foxtail (meadow foxtail grass)

Alopecurus pratensis.

g17
Bahia grass

Paspalum notatum.

g24
Wheat grass, Western

Agropyron smithii
(
Elymus smithii
).

g30
Bluegrass, annual

Poa annua.

g70
Wild rye grass

Elymus triticoides

Elymus condensatus.

g71
Canary grass

Phalaris arundinacea.

g201
Barley, cultivated

Hordeum vulgare.

g202
Maize, corn (cultivated corn)

Zea mays.

g203
Salt grass

Distichlis spicata.

g204
False oat-grass

Arrhenatherum elatius.

g216
Cyn d 1

Cynodon dactylon.

g701
Phl p 1.0102, Phl p 5.0101

Phleum pratense.

g702
Phl p 7.0101

Phleum pratense.

g703
Phl p 12.0101

Phleum pratense.

Weed Pollens

w2
Western ragweed

Ambrosia psilostachya.

w4
False ragweed

Ambrosia acanthicarpa
(
Franseria acanthicarpa
).

w5
Wormwood

Artemisia absinthium

Artemisia annua.

w6
Mugwort

Artemisia vulgaris.

w7
Marguerite, ox-eye daisy

Chrysanthemum leucanthemum.

w8
Dandelion

Taraxacum vulgare
,
Taraxacum officinale.

w9
Plantain (English), Ribwort

Plantago lanceolata.

w10
Goosefoot, lamb's quarters

Chenopodium album.

w11
Saltwort (prickly), Russian thistle

Salsola kali
(
Salsola pestifer
).

w12
Goldenrod

Solidago virgaurea
(
Solidago
spp.).

w13
Cocklebur, common

Xanthium commune.

w14
Common pigweed (rough pigweed)

Amaranthus retroflexus.

w15
Scale, Lenscale

Atriplex lentiformis.

w16
Rough marsh elder

Iva ciliate
,
Iva annua.

w17
Firebush (Kochia)

Kochia scoparia.

w18
Sheep sorrel

Rumex acetosella.

w19
Wall pellitory

Parietaria officinalis.

w20
Nettle (Common stinging nettle)

Urtica dioica.

w21
Wall pellitory

Parietaria judaica.

w22
Japanese hop (careless weed)

Humulus japonicas
(
Humulus scandens
).

w23
Yellow dock, Yellow dockweed

Rumex crispus.

w24
Spiny pigweed

Amaranthus spinosus.

w27
Carnation

Dianthus
spp.

w28
Rose

Rosa rugosa.

w33
Clover

Trifolium pratense.

w35
Mexican tea

Chenopodium ambrosioides.

w36
Rabbit bush

Ambrosia deltoidea
(
Franseria deltoides
).

w37
Salt bush, annual

Atriplex wrightii.

w39
Water hemp, Western

Amaranthus rudis
(
Acnida tamariscina
).

w41
Burrobrush

Hymenoclea salsola.

w42
Poverty weed

Baccharis neglecta.

w43
Common sagebrush

Artemisia tridentata.

w45
Alfalfa

Medicago sativa.

w46
Dog fennel

Eupatorium capillifolium.

w53
Geranium

Geranium
spp.

w67
Groundsel bush

Baccharis halimifolia.

w69
Iodine bush

Allenrolfea occidentalis.

w70
Ragweed, slender

Ambrosia confertiflora.

w75
Wing scale (wingscale)

Atriplex canescens.

w82
Careless weed

Amaranthus palmeri
,
Amaranthus hybridus.

w90
Japanese hop

Humulus japonicas
(
Humulus scandens
).

w203
Rape (rape pollen)

Brassica napus.

w204
Sunflower

Helianthus annuus.

w206
Camomile

Matricaria chamomilla.

w207
Lupin

Lupinus
spp.

w210
Sugar-beet

Beta vulgaris.

w211
Par j 2.0101

Parietaria judaica.

w231
Art v 1

Artemisia vulgaris
(Mugwort).

w232
Sal k 1

Salsola kali.

w233
Art v 3

Artemisa vulgaris
(LTP, Mugwort).

w234
Pla l 1

Plantago lanceolata.

w235
Che a 1.0101

Chenopodium album.

w236
Mer a 1.0101

Mercurialis annua.

a753
Art v 1

Artemisia vulgaris
(Mugwort weed).

Tree Pollens

t1
Box-elder (Maple)

Acer negundo
,
Acer saccharum.

t2
Gray alder, speckled alder (alder)

Alnus incana.

t4
Hazel, hazelnut

Corylus avellana
,
Corylus americana.

t5
American beech (beech)

Fagus grandifolia
(
Fagus americana
).

t6
Mountain juniper, Mountain cedar

Juniperus ashei
(
Juniperus sabinoides
).

t8
Elm

Ulmus americana.

t9
Olive

Olea europaea.

t10
Walnut

Juglans californica
,
Juglans nigra.

t11
Maple leaf sycamore, London plane, Plane tree

Platanus acerifolia.

t61
Sycamore

Platanus occidentalis.

t12
Willow

Salix caprea
,
Salix nigra.

t14
Cottonwood (Eastern Cottonwood/Black Cottonwood)

Populus deltoides.

t15
White ash

Fraxinus americana.

t16
White pine

Pinus strobus.

t18
Eucalyptus, gum-tree

Eucalyptus globulus
(
Eucalyptus
spp.).

t19/t26
Acacia

Acacia longifolia
(
Acacia
spp.).

t20
Mesquite

Prosopis glandulosa/
Prosopis juliflora.

t21
Melaleuca, cajeput tree

Melaleuca quinquenervia
(
Melaleuca leucadendron
).

t22
Pecan, hickory

Carya illinoinensis
(
Carya pecan
).

t23
Italian/Mediterranean/funeral cypress

Cupressus sempervirens.

t24
Japanese cypress

Chamaecyparis obtusa
(
Chamaecyparis
spp.).

t25
Ash

Fraxinus excelsior.

t27
Maple, red

Acer rubrum.

t29
Acacia

Acacia
spp.

t30
Birch, white

Betula populifolia.

t32
Willow, black

Salix nigra.

t33
Ash, Arizona

Fraxinus velutina.

t35
Cedar, salt

Tamarix gallica.

t37
Bald cypress (white bald cypress)

Taxodium distichum.

t38
Elm, Chinese/Siberian

Ulmus pumila.

t40
Hazelnut tree

Corylus americana.

t41
White hickory

Carya alba
(
Carya tomentosa
).

t42
Oak, red

Quercus rubra.

t43
Loblolly pine

Pinus taeda.

t44
Hackberry

Celtis occidentalis.

t45
Cedar elm

Ulmus crassifolia.

t47
Juniper, one seed

Juniperus monosperma.

t48
Pine, lodgepole

Pinus contorta.

t49
Pine, ponderosa

Pinus ponderosa.

t50
Beech, European

Fagus sylvatica.

t51
Tree of Heaven

Ailanthus altissima.

t52
Western white pine

Pinus monticola.

t54
Russian olive

Elaeagnus angustifolia.

t55
Scotch broom

Cytisus scoparius.

t56
Bayberry

Myrica cerifera.

t57
Red cedar

Juniperus virginiana.

t60
Western juniper

Juniperus occidentalis.

t61
Sycamore

Platanus occidentalis.

t70
Mulberry (white mulberry)

Morus alba.

t71
Red mulberry

Morus rubra.

t72
Queen palm

Arecastrum romanzoffiamon.

t73
Australian pine

Casuarina equisetifolia.

t77
Oak mix (red, white, black)

Quercus
spp.

t80
Japanese cypress

Chamaecyparis obtusa.

t81
Japanese alder

Alnus japonica.

t83
Mango tree

Mangifera indica.

t90
Walnut, black

Juglans nigra.

t96
Poplar, white (poplar)

Populus alba.

t103/t218
Virginia live oak (live oak)

Quercus virginiana.

t105
Pepper tree

Schinus molle.

t110
Orange tree

Citrus sinensis.

t201
Spruce, Norway spruce

Picea abies
(
Picea excelsa
).

t202
Alder, smooth

Alnus incana
spp.
Rugosa
(
Alnus rugosa
).

t203
Horse chestnut

Aesculus hippocastanum.

t205
Elder

Sambucus nigra.

t206
Chestnut

Castanea sativa.

t207
Douglas fir

Pseudotsuga menziesii
(
Pseudotsuga taxifolia
).

t208
Linden

Tilia cordata.

t209
Horn beam

Carpinus betulus.

t210
Privet

Ligustrum vulgare.

t211
Sweet gum

Liquidambar styraciflua.

t212
Cedar

Libocedrus decurrens.

t213
Pine

Pinus radiata.

t214
Date palm

Phoenix canariensis.

t215
Lilac

Syringa vulgaris.

t217
Pepper tree

Schinus molle.

t217
Red alder

Alnus rubra.

t218
Virginia live oak

Quercus virginiana.

t218
Bayberry (bayberry/sweet gale)

Myrica gale.

t219
Palo verde

Cercidium floridum.

t219
Red cedar

Juniperus virginiana.

t220
Bet v 4

Betula verrucosa
(Birch).

t221
Bet v 2.0101, Bet v 4

Betula verrucosa
(Birch).

t222
Cypress (Arizona cypress)

Cupressus arizonica.

t223
Oil palm

Elaeis guineensis.

t224
Ole e 1

Olea europaea.

t225
Bet v 6

Betula verrucosa
(Birch).

t226
Cup a 1

Cupressus arizonica.

t227
Ole e 7

Olea Europaea.

t228
Aspen, quaking

Populus tremuloides.

t229
Eastern hemlock

Tsuga canadensis.

t230
Redwood (sequoia)

Sequoia sempervirens.

t232
Pussy willow

Salix discolor.

t240
Ole e 9.0101

Olea Europaea.

t241
Pla a 1.0101

Platanus acerifolia.

t242
Pla a 2

Platanus acerifolia.

t243
Pla a 3.0101

Platanus acerifolia.

t244
Cor a 1.0103

Corylus avellana.

t245
Aln g 1.0101

Alnus glutinosa.

t246
Cry j 1

Cryptomeria japonica.

t280
Locust tree

Robinia pseudoacacia.

t401
Brazilian peppertree

Schinus terebinthifolius.

t402
Mastic tree

Pistacia lentiscus.

t404
Tree of heaven

Ailanthus altissima.

t406
Date palm

Phoenix dactylifera.

a482
Ole e 1

Olea europaea
(Olive Oil).

Mites

d207
Blo t 5.0101

Blomia tropicalis.

d208
Lep d 2.0101

Lepidoglyphus destructor.

Microorganisms, Molds, Yeast

m1

Penicillium chrysogenum
(
Penicillium notatum
)

Penicillium chrysogenum
(
Penicillium notatum
).

m2

Cladosporium herbarum
(
Hormodendrum
)

Cladosporium herbarum
(
Hormodendrum
).

m3

Aspergillus fumigatus

Aspergillus fumigatus.

m4

Mucor racemosus

Mucor racemosus.

m5

Candida albicans

Candida albicans.

m7

Botrytis cinerea

Botrytis cinerea.

m8

Drechslera halodes
(
Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum
)

Drechslera halodes
(
Setomelanomma rostrata, Helminthosporium halodes.

m9

Fusarium moniliforme
(
Fusarium proliferatum
)

Fusarium moniliforme
(
Fusarium proliferatum
).

m10

Stemphylium botryosum

Stemphylium herbarum
(
Stemphylium botryosum
).

m11

Rhizopus nigricans

Rhizopus nigricans.

m12

Aureobasidium pullulans

Aureobasidium pullulans.

m13

Phoma betae

Phoma betae.

m14

Epicoccum purpurascens

Epicoccum purpurascens
(
Epicoccum nigrum
).

m15

Trichoderma viride

Trichoderma viride.

m16

Curvularia lunata

Curvularia lunata
,
Curvularia specifera
(
K923044
).

m17

Cladosporium fulvum

Cladosporium fulvum.

m18

Fusarium culmorum

Fusarium culmorum.

m19

Aspergillus versicolor

Aspergillus versicolor.

m20

Mucor mucedo

Mucor mucedo.

m21

Aspergillus clavatus

Aspergillus clavatus.

m22

Micropolyspora faeni

Saccharopolyspora rectivirgula
(
Micropolyspora faeni
).

m23

Thermoactinomyces vulgaris

Thermoactinomyces vulgaris.

m24

Stachybotrys atra

Stachybotrys chartarum
(
Stachybotrys atra
).

m24

Paecilomyces
spp

Paecilomyces
spp.

m25

Aspergillus versicolor

Aspergillus versicolor.

m25

Penicillium brevicompactum

Penicillium brevicompactum.

m26

Cladosporium cladosporioides

Cladosporium cladosporioides.

m26

Penicillium citrinum

Penicillium citrinum.

m27

Penicillium
spp

Penicillium
spp.

m29

Aspergillus repens

Aspergillus repens.

m30

Penicillium roqueforti

Penicillium roqueforti.

m32

Cladosporium cladosporioides

Cladosporium cladosporioides.

m34

Serpula lacrymans

Serpula lacrymans.

m36

Aspergillus terreus

Aspergillus terreus.

m37

Trichophyton mentagrophytes

Trichophyton mentagrophytes.

m40

Aspergillus amstelodami

Aspergillus amstelodami.

m43

Saccharomyces Carlsberg

Saccharomyces carlsbergensis.

m44

Saccharomyces cerevisiae

Saccharomyces cerevisiae.

m45

Hormodendrum hordei

Hormodendrum hordei.

m46

Bipolaris spicifera

Bipolaris spicifera.

m47

Aspergillus nidulans

Aspergillus nidulans.

m48

Aspergillus oryzae

Aspergillus oryzae.

m49

Fusarium oxysporum

Fusarium oxysporum.

m50

Micropolyspora faeni

Saccharopolyspora rectivirgula
(
Micropolyspora faeni
).

m51

Thermoactinomyces vulgaris

Thermoactinomyces vulgaris.

m53

Microspora canis

Microsporum canis
(
Microspora canis
).

m54

Aspergillus flavus

Aspergillus flavus.

m63

Helminthosporium intersemin

Helminthosporium intersemin.

m66

Mucor plumbeus

Mucor plumbeus.

m67

Mycogone

Mycogone perniciosa.

m68

Nigrospora oryzae

Nigrospora oryzae.

m69

Rhodotorula

Rhodotorula rubra
(
Rhodotorula mucilaginosa
).

m70

Malassezia furfur
(
Pityrosporum orbiculare
)

Malassezia furfur
(
Pityrosporum orbiculare
).

m71

Spondylocladium

Spondylocladium
spp.

m72

Epidermophyton

Epidermophyton floccosum.

m73

Epicoccum nigrum

Epicoccum purpurascens
(
Epicoccum nigrum
).

m80

Staphylococcal enterotoxin A
(
Sta a SEA
)

Staphylococcus aureus.

m80

Helminthosporium
spp

Helminthosporium
spp.

m81

Staphylococcal enterotoxin B
(
Sta a SEB
)

Staphylococcus aureus.

m88

Stemphylium solani

Stemphylium solani.

m93

Gliocladium fimbriatum

Gliocladium fimbriatum.

m94

Phycomyces blakesleeanus

Phycomyces blakesleeanus.

m201

Tilletia tritici
(
Ustilago nuda, Ustilago tritici
) (Barley smut)

Tilletia tritici
(
Ustilago nuda, Ustilago tritici
).

m202

Acremonium kiliense
(
Cephalosporium acremonium
)

Acremonium kiliense
(
Cephalosporium acremonium
).

m203

Trichosporon pullulans

Trichosporon pullulans.

m204

Ulocladium chartarum

Ulocladium chartarum.

m205

Trichophyton rubrum

Trichophyton rubrum.

m207

Aspergillus niger

Aspergillus niger.

m208

Chaetomium globosum

Chaetomium globosum.

m209

Penicillium frequentans

Penicillium glabrum
(
Penicillium frequentans
).

m209

Stachybotrys chartarum

Stachybotrys chartarum
(
Stachybotrys atra
).

m210

Trichophyton mentagrophytes var. goetzii

Trichophyton mentagrophytes var. goetzii.

m211

Trichophyton mentagrophytes var. interdigitale

Trichophyton mentagrophytes var. interdigitale.

m211
Oat smut

Ustilago avenae.

m212

Micropolyspora faeni

Saccharopolyspora rectivirgula
(
Micropolyspora faeni
).

m212

Geotrichum candidum

Geotrichum candidum.

m213
Bermuda grass smut

Ustilago cynodontis.

m214
Johnson grass smut

Sphacelotheca cruenta.

m215
Corn smut

Ustilago maydis.

m218
Asp f 1.0101

Aspergillus fumigatus.

a3050
Asp r 1

Aspergillus restrictus.

m219
Asp f 2

Aspergillus fumigatus.

m220
Asp f 3.0101

Aspergillus fumigatus.

m221
Asp f 4

Aspergillus fumigatus.

m222
Asp f 6.0101

Aspergillus fumigatus.

m223

Staphylococcal enterotoxin C
(
Sta a SEC
)

Staphylococcus aureus.

m224

Staphylococcal enterotoxin D
(
Sta a SED
)

Staphylococcus aureus.

m226

Staphylococcal enterotoxin TSST
(
Sta a TSST
)

Staphylococcus aureus.

m227

Malassezia
spp. (
Pityrosporum
spp.)

Malassezia
spp. (
Pityrosporum
spp.).

m228

Aspergillus flavus.

m229
Alt a 1.0101

Alternaria alternata
(
Alternaria tenuis
).

m230
Alt a 6.0101

Alternaria alternata
(
Alternaria tenuis
).

m231
Cla h 8.0101

Cladosporium herbarum
(
Hormodendrum
).

m300

Eurotium
spp

Eurotium
spp.

m304

Aspergillus oryzae

Aspergillus oryzae.

m305

Penicillium brevicompactum

Penicillium brevicompactum.

m309

Aspergillus terreus

Aspergillus terreus.

m310

Aspergillus nidulans

Aspergillus nidulans.

m311

Aspergillus flavus

Aspergillus flavus.

m312

Aspergillus clavatus

Aspergillus clavatus.

Epidermal & Animal

e6
Guinea pig epithelium

Cavia porcellus.

e7
Pigeon droppings

Columba palumbus
,
Columba livia.

e25
Chicken serum

Gallus domesticus
(
Gallus gallus domesticus; Gallus
spp.).

e26
Parrot serum

Psittacoidea
spp.

e62
Camel

Camelus dromedaries.

e70
Goose feathers

Anser anser.

e71
Mouse epithelium

Mus musculus
(
Mus
spp.).

e73
Rat epithelium

Rattus norvegicus.

e74
Rat urine proteins

Rattus norvegicus
,
Rattus rattus.

e75
Rat serum proteins

Rattus norvegicus
,
Rattus rattus.

e76
Mouse serum proteins

Mus musculus
(
Mus
spp.).

e77
Budgerigar droppings

Melopsittacus undulatus.

e78
Budgerigar feathers

Melopsittacus undulatus.

e79
Budgerigar serum proteins

Melopsittacus undulatus.

e80
Goat epithelium

Capra hircus.

e81
Sheep epithelium

Ovis aries
(
Ovis
spp.).

e82
Rabbit epithelium

Oryctolagus cuniculus
(
Oryctolagus
spp.).

e83
Swine epithelium

Sus scrofa
(
Sus scrofa domesticus; Sus
spp.).

e84
Hamster epithelium

Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus.

e85
Chicken feathers

Gallus domesticus
(
Gallus gallus domesticus; Gallus
spp.).

e86
Duck feathers

Anas platyrhynchos.

e87
Rat epithelium, serum proteins, and urine proteins

Rattus norvegicus

Rattus rattus.

e88
Mouse epithelium, serum proteins, and urine proteins (mouse)

Mus musculus
(
Mus
spp.).

e89
Turkey feathers

Meleagris gallopavo.

e90
Budgerigar serum proteins, feathers, and droppings

Melopsittacus undulatus.

e91
Pigeon serum proteins, feathers, and droppings

Streptopelia roseogrisea
,
Psittacidae
spp.

e92
Parrot serum proteins, feathers, and droppings

Ara
spp.

e93
Pigeon serum proteins

Streptopelia roseogrisea.

e94
Fel d 1.0101

Felis domesticus.

a345
Fel d 1

Felis domesticus.

e98
Parrot droppings

Psittacoidea
spp.

e101
Can f 1.0101

Canis familiaris
(
Canis domesticus
).

a174
Can f 1

Canis familiaris
(
Canis domesticus
).

e102
Can f 2.0101

Canis familiaris
(
Canis domesticus
).

e196
Parakeet feathers

Nymphicus hollandicus.

e197
Parakeet droppings

Nymphicus hollandicus.

e198
Parakeet serum

Nymphicus hollandicus.

e199
Canary bird serum

Serinus canarius.

e200
Canary bird droppings

Serinus canarius.

e201
Canary bird feathers (Canary feathers)

Serinus canarius.

e202
Reindeer epithelium

Rangifer tarandus.

e203
Mink epithelium

Mustela
spp.

e204
Bos d 6

Bos domesticus
(
Bos taurus; Bos
spp.).

e205
Horse, serum proteins

Equus caballus
(
Equus
spp.).

e206
Rabbit, serum proteins

Oryctolagus cuniculus
(
Oryctolagus
spp.).

e208
Chinchilla epithelium

Chinchilla laniger.

e209
Gerbil epithelium

Meriones unguiculatus.

e210
Fox epithelium

Vulpes vulpes.

e211
Rabbit, urine proteins

Oryctolagus cuniculus
(
Oryctolagus
spp.).

e212
Swine, urine proteins

Sus scrofa
(
Sus scrofa domesticus; Sus
spp.).

e213
Parrot feathers

Ara
spp.

e214
Finch feathers

Lonchura domestica.

e215
Pigeon feathers

Streptopelia roseogrisea
(
Streptopelia
spp.),
Columbia
spp.

e216
Deer epithelium

Dama dama.

e217
Ferret epithelium

Mustela putorius.

e218
Chicken droppings

Gallus domesticus
(
Gallus gallus domesticus; Gallus
spp.).

e219
Chicken, serum proteins

Gallus domesticus
(
Gallus gallus domesticus; Gallus
spp.).

e220
Fel d 2, Cat serum albumin

Felis domesticus.

e221
Can f 3

Canis familiaris
(
Canis domesticus
) (
Dog serum albumin
).

e222
Swine serum albumin (Sus s PSA)

Sus scrofa
(
Sus scrofa domesticus; Sus
spp.).

e225
Lovebird feathers

Psittacoidea agapomis.

e226
Can f 5.0101

Canis familiaris.

e227
Equ c 1.0101

Equus caballus.

e228
Fel d 4.0101

Felis domesticus.

e230
Equ c 3

Equus caballus.

e231
Mus m 1

Mus musculus.

Food

f9
Rice

Oryza sativa.

f12
Pea (green pea)

Pisum sativum.

f15
White bean

Phaseolus vulgaris.

f19
Cayenne pepper

Capsicum frutescens
(
Capsicum annum
).

f21
Sugar cane

Saccharum officinarum.

f22
Raspberry

Rubus idaeus.

f26
Pork

Sus scrofa
(
Sus scrofa domesticus; Sus
spp.).

f29
Watermelon

Citrullus lanatus
(
Citrullus vulgaris
).

f31
Carrot

Daucus carota.

f32
Oyster mushroom

Pleurotus ostreatus.

f33
Orange

Citrus sinensis.

f35
Potato

Solanum tuberosum.

f43
Mother's milk

Homo sapiens.

f44
Strawberry

Fragaria vesca
(
Fragaria
spp.).

f45
Yeast, baker's

Saccharomyces cerevisiae.

f46
Pepper, Red

Capsicum annuum.

f47
Garlic

Allium sativum.

f48
Onion

Allium cepa.

f49
Apple

Malus x domestica
(
Malus
spp.).

f51
Bamboo shoot

Phyllostachys pubescens.

f52
Cacao/chocolate

Theobroma cacao.

f54
Sweet potato

Ipomoea batatas.

f55
Common millet

Panicum miliaceum.

f56
Foxtail millet

Setaria italica.

f57
Japanese millet

Echinochloa crus-galli.

f58
Pacific squid

Todarodes pacificus.

f59
Octopus

Octopus vulgaris
(
Octopus
spp.).

f63
Kefir
NA.

f67
Parmesan cheese
NA.

f81
Cheese, cheddar type
NA.

f82
Cheese, mold type
NA.

f83
Chicken

Gallus domesticus
(
Gallus gallus domesticus; Gallus
spp.).

f86
Parsley

Petroselinum crispum.

f87
Melon

Cucumis melo Cucumis melo + Citrullus lanatus.

f88
Mutton (lamb)

Ovis aries
(
Ovis
spp.).

f90
Malt

Hordeum vulgare.

f92
Banana

Musa
spp.

f93
Cacao

Theobroma cacao.

f94
Pear

Pyrus communis
(
Pyrus
spp.).

f97
Yam

Dioscorea
spp.
Dioscorea opposita.

f97
Chamomile tea

Matricaria chamomilla.

f98
Gliadin

Triticum aestivum
(
Triticum
spp.).

f102
Cantaloupe

Cucumis melo var. cantalupensis.

f105
Chocolate

Theobroma cacao.

f109
Cottonseed

Gossypium hirsutum.

f110
Giant radish

Raphanus sativus.

f118
Zucchini

Cucurbita pepo.

f119
Radish

Raphanus sativus.

f120
Venison

Capreolus capeolus.

f121
Pinto bean

Phaseolus vulgaris.

f122
Cheese, American
NA.

f127
Black-eyed pea

Vigna unguiculata.

f131
Black Olive

Olea europaea.

f136
Red beet

Beta vulgaris var. conditiva.

f139
Goat's Cheese

Capra aegagrus.

f140
Bran
NA.

f141
Corn (vegetables)

Zea mays.

f152
Green bell pepper

Capsicum annuum.

f155
Brewer's yeast

Saccharomyces carlsbergensis.

f157
Duck

Anas domesticus.

f158
Goose

Anser anser.

f160
Camembert cheese
NA.

f162
Nectarine

Prunus persica var. nucipersica.

f163
Kohlrabi

Brassica oleracea var. gongylodes.

f65
Perch

f166
Leek

Allium porrum.

f170
Cheese (Switzerland) (Swiss cheese)
NA.

f174
Fig

Ficus carica.

f177
Cranberry

Vaccinium macrocarpon.

f179
Raisin

Vitis
spp.

f182
Lima bean

Phaseolus lunatus.

f198
Flaxseed (bruised grain)

Linum usitatissimum.

f199
Untreated native milk

Bos domesticus
(
Bos taurus; Bos
spp.).

f208
Lemon

Citrus limon.

f209
Grapefruit

Citrus paradisi.

f210
Pineapple

Ananas comosus.

f211
Blackberry

Rubus fruticosus.

f212
Mushroom (champignon)

Agaricus hortensis
(
Agaricus
spp.).

f213
Rabbit

Oryctolagus cuniculus
(
Oryctolagus
spp.).

f214
Spinach

Spinacia oleracea.

f215
Lettuce

Lactuca sativa.

f216
Cabbage

Brassica oleracea var. capitata.

f217
Brussels sprouts

Brassica oleracea var. gem.

f218
Paprika, sweet pepper

Capsicum annuum.

f219
Fennel seed

Foeniculum vulgare.

f219
Sage

Salvia officinalis.

f220
Cinnamon

Cinnamomum
spp.

f221
Coffee

Coffea
spp.

f222
Tea

Camellia sinensis.

f223
Green olive

Olea europaea.

f225
Summer squash, pumpkin

Cucurbita pepo.

f225
Pumpkin

Cucurbita maxima.

f226
Pumpkin seed

Cucurbita pepo.

f227
Sugar-beet seed

Beta vulgaris.

f229
Safflower Seed

Carthamus tinctorius.

f231
Milk, boiled

Bos domesticus
(
Bos taurus; Bos
spp.).

f234
Vanilla

Vanilla planifolia.

f237
Apricot

Prunus armeniaca.

f241
Gouda cheese
NA.

f242
Cherry

Prunus avium.

f244
Cucumber

Cucumis sativus.

f246
Guar, guar gum

Cyamopsis tetragonoloba.

f247
Honey
NA.

f248
Rosemary

Rosmarinus officinalis.

f254
Plaice

Pleuronectes platessa.

f255
Plum

Prunus domestica
,
Prunus americana.

f258
Squid

Loligo
spp.

f259
Grape

Vitis vinifera
(
Vitis
spp.).

f260
Broccoli

Brassica oleracea var. italica
(
Brassica oleracea var. cultivar
).

f261
Asparagus

Asparagus officinalis.

f262
Aubergine, eggplant

Solanum melongena.

f263
Green pepper

Piper nigrum
,
Capsicum annuum.

f264
Eel

Anguilla anguilla.

f265
Caraway

Carum carvi.

f265
Cumin

Cuminum cyminum.

f266
Mace

Myristica fragrans.

f267
Cardamon

Elettaria cardamomum.

f268
Clove

Syzygium aromaticum.

f269
Basil

Ocimum basilicum.

f270
Ginger

Zingiber officinale.

f271
Anise

Pimpinella anisum.

f272
Tarragon

Artemisia dracunculus.

f273
Thyme

Thymus vulgaris.

f274
Marjoram

Origanum majorana.

f275
Lovage

Levisticum officinale.

f276
Fennel, fresh

Foeniculum vulgare.

f277
Dill

Anethum graveolens.

f278
Bay leaf

Laurus nobilis.

f279
Chili pepper

Capsicum frutescens.

f280
Black pepper

Piper nigrum.

f281
Curry (Santa Maria)
NA.

f282
Nutmeg

Myristica fragrans.

f283
Oregano

Origanum vulgare.

f284
Turkey meat

Meleagris gallopavo.

f285
Elk/moose meat

Alces
spp.

f286
Mare's milk

Equus caballus
(
Equus
spp.).

f287
Red kidney bean

Phaseolus vulgaris.

f288
Blueberry

Vaccinium myrtillus
(
Vaccinium
spp.).

f289
Date

Phoenix dactylifera.

f291
Cauliflower

Brassica oleracea var. botrytis.

f292
Guava

Psidium guajava.

f293
Papaya

Carica papaya.

f294
Passion fruit, Maracuja

Passiflora edulis
(
Passiflora
spp.).

f295
Carambola

Averrhoa carambola.

f296
Carob

Ceratonia siliqua.

f297
Gum Arabic

Acacia senegal
(
Acacia
spp.).

f298
Tragacanth

Astragalus
spp.

f299
Sweet chestnut (chestnut)

Castanea sativa.

f300
Pinto bean

Phaseolus
spp.

f301
Persimmon (kaki fruit, sharon)

Diospyros kaki.

f302
Mandarin (tangerine, clementine, satsumas)

Citrus reticulata.

f305
Fenugreek

Trigonella foenum-graecum.

f306
Lime

Citrus aurantifolia.

f307
Hake

Merluccius merluccius.

f308
Sardine (pilchard)

Sardina pilchardus.

f310
Blue vetch

Lathyrus sativus.

f311
Megrim

Lepidorhombus whiffiagonis.

f315
Green bean

Phaseolus vulgaris.

f316
Rape seed

Brassica napus.

f317
Coriander

Coriandrum sativum.

f318
Jack fruit

Artocarpus heterophyllus.

f319
Beetroot

Beta vulgaris.

f320
Crayfish

Astacus astacus.

f321
Horse meat

Equus caballus
(
Equus
spp.).

f322
Red currant

Ribes sylvestre.

f324
Hop (fruit cone)

Humulus lupulus.

f325
Saffron

Colchicum autumnale.

f328
Fig

Ficus carica.

f329
Watermelon

Citrullus lanatus.

f330
Rose hip

Rosa
spp.

f331
Saffron

Crocus sativus.

f332
Mint

Mentha piperita.

f333
Linseed

Linum usitatissimum.

f336
Jujube

Ziziphus jujuba.

f336
Wine vinegar

Vitis vinifera
(
Vitis
spp.).

f337
Sole

Solea solea.

f337
English sole

Parophrys vetulus.

f338
Wine, white

Vitis vinifera
(
Vitis
spp.).

f339
Allspice

Pimenta dioica.

f339
Wine, red

Vitis vinifera
(
Vitis
spp.).

f341
Cranberry

Vaccinium oxycoccus
,
Vaccinium macrocarpon.

f342
Olive (black, fresh)

Olea europaea.

f343
Raspberry

Rubus idaeus.

f344
Sage

Salvia officinalis.

f346
Chives

Allium schoenoprasum.

f347
Quinoa

Chenopodium quinoa.

f348
Litchi

Litchi chinensis.

f349
Chum salmon roe

Oncorhynchus keta.

f358
Artichoke

Cynara scolymus.

f360
Yogurt
NA.

f368
Black bass

Micropterus dolomieu
(
Micropterus dolomieui
).

f374
Karaya gum

Sterculia urens.

f375
Horseradish

Armoracia rusticana.

f377
Maple syrup
NA.

f379
Okra

Abelmoschus esculentus.

f382
Beet, sugar

Beta vulgaris var. altissima.

f401
Loquat

Eriobotrya japonica.

f402
Fig

Ficus carica.

f403
Brewer's yeast

Saccharomyces cerevisiae.

f405
Mint

Mentha
spp.

f406
Arugula

Eruca vesicaria.

House Dust

h1
Greer Labs., Inc
NA.

h2
Hollister-Stier Labs
NA.

h6
Japan
NA.

Venoms & Insects

i7
Midge

Chironomus yoshimatsui.

i8
Moth

Bombyx mori
,
Heterocera
spp.

i47
Water flea

Daphnia
spp.

i49
Deer fly

Chrysops
spp.

i51
Black ant

Camponotus pennsylvanicus.

i54
Flea mix (dog/cat), common flea

Ctenocephalides
spp.

i71
Mosquito

Aedes communis
,
Aedes
spp.
and Culex
spp.

i72
Green nimitti

Cladotanytarsus lewisi.

i73
Blood worm

Chironomus thummi
,
Chironomusri parius
,
Chironomus
spp.

i75
European hornet

Vespa crabro.

i76
Berlin beetle

Trogoderma angustum.

i77
European paper wasp

Polistes dominulus.

i78
Fly

Musca domestica.

i80
Bumblebee

Bombus pennsylvanicus.

i201
Horse bot fly

Gasterophilus intestinalis.

i202
Grain weevil

Sitophilus granarius.

i203
Mediterranean flour moth

Ephestia kuehniella
(
Anagasta kuehniella
).

i204
Horse fly

Tabanus
spp.

i205
Bumblebee

Bombus terrestris.

i208
Api m 1.0101

Apis mellifera.

a45
Api m 1

Apis mellifera.

i209
Ves v 5.0101

Vespula vulgaris.

a670
Ves v 5

Vespula vulgaris.

i210
Pol d 5.0101

Polistes dominulus.

i211
Ves v 1.0101

Vespula vulgaris.

i213
Api m 4

Apis mellifera.

i214
Api m 2

Apis mellifera.

i215
Api m 3

Apis mellifera.

i216
Api m 5

Apis mellifera.

i217
Api m 10

Apis mellifera.

i220
Bla g 1.0101

Blattella germanica.

i221
Bla g 2.0101

Blattella germanica.

i222
Bla g 5.0101

Blattella germanica.

i223
Bla g 7

Blattella germanica.

a46
Api m 2

Apis mellifera.

Miscellaneous

o1
Cotton, crude fibers

Gossypium
spp.

o3
Cotton (treated)

Gossypium
spp.

o70
Seminal fluid

Homo sapiens.

o71

Staphylococcus aureus

Staphylococcus aureus.

o72

Pichia pastoris
crude extract customer specific

Pichia pastoris.

o72
Sperm-sediment

Homo sapiens.

o73

Pichia pastoris
crude extr. vector customer specific

Pichia pastoris.

o74

Pichia pastoris
with vector customer specific

Pichia pastoris.

o201
Tobacco leaf, tobacco dust

Nicotiana tabacum.

o202
Artemia salina, fish feed

Artemia salina.

o203
Tetramin, fish feed
NA.

o207
Daphnia, fish feed

Daphnia
spp.

o211
Mealworm

Tenebrio molitor.

o212
Streptavidin

Streptomyces avidini.

o213
MBP (maltose binding protein)

Escherichia coli.

o214
CCD; MUXF3 from bromelain

Ananas comosus.

o72
Enterotoxin A (Sta a SEA)

Staphylococcus aureus.

o73
Enterotoxin B (Sta a SEB)

Staphylococcus aureus.

Parasites

p1
Ascaris

Ascaris suum.

p2
Echinococcus

Echinococcus granulosus.

p3
Schistosoma

Schistosoma mansoni.

p4
Anisakis (Herring Worm)

Anisakis simplex
(
Anisakis
spp.).

p5
Toxocara canis

Toxocara canis.

p10
Ani s 3.0101

Anisakis simplex
(
Anisakis
spp.).

p11
Ani s 1

Anisakis simplex
(
Anisakis
spp.).

Occupational

k4
Threshing dust
NA.

k5
Flax
NA.

k7
Hay Dust
NA.

k8
Hop (hops)

Humulus lupulus.

k12
Grain mill dust
NA.

k14
Kapok
NA.

k20
Sheep's wool (treated) (wool)

Ovis aries
(
Ovis
spp.).

k21
Sheep's wool (Untreated)

Ovis aries
(
Ovis
spp.).

k23
Straw Dust
NA.

k33
Oak
NA.

k70
Green coffee bean

Coffea
spp.

k71
Castor bean

Ricinus communis.

k72
Ispaghula

Plantago psyllium/Plantago ovata.

k73
Silk waste
NA.

k74
Silk

Bombyx mori.

k75
Isocyanate TDI (Toluene diisocyanate)
NA.

k76
Isocyanate MDI (Diphenylmethane diisocyanate)
NA.

k77
Isocyanate HDI (Hexamethylen diisocyanate)
NA.

k78
Ethylene oxide
NA.

k79
Phthalic anhydride
NA.

k80
Formaldehyde/Formalin
NA.

k81
Ficus

Ficus benjamina
(
Ficus
spp.).

k83
Cotton seed

Gossypium hirsutum.

k84
Sunflower seed

Helianthus annuus.

k85
Chloramin T
NA.

k86
Trimellitic anhydride, TMA
NA.

k87
Asp o 21, alpha-amylase

Aspergillus oryzae.

k89
Orris root

Iris florentina.

k99
HSA (Human Serum Albumin) (Hom s HSA)

Homo sapiens.

k201
Car p 1, Papain

Carica papaya.

k202
Ana c 2, Bromelain

Ananas comosus.

k204
Maxatase

Bacillus licheniformis.

k205
Alcalase

Bacillus
spp.

k206
Savinase, Protease 1 (Bac l Subtilisin)

Bacillus
spp.

k208
Gal d 4, Lysozyme

Gallus domesticus
(
Gallus gallus domesticus; Gallus
spp.).

k209
Hexahydrophtalic anhydrid
NA.

k210
Maleic anhydride
NA.

k211
Methyltetrahydrophtalic anhydrid
NA.

k212
Abachi wood dust

Triplochiton scleroxylon.

k213
Pepsin (Sus s Pepsin)

Sus scrofa
(
Sus scrofa domesticus; Sus
spp.).

k213
TCPA
NA.

k214
Bougainvillea

Bougainvillea
spp.

k225
Horse radish peroxidase (Arm r HRP)

Armoracia rusticana.

k226
Ascorbate oxidase (Cuc p ascorbate oxidase)

Cucurbita pepo.

k301
Flour dust

Triticum
spp.

k501
Savinase customer specific
Proprietary knowledge of customer.

k502
Lipolase customer specific
Proprietary knowledge of customer.

k503
Termamyl customer specific
Proprietary knowledge of customer.

k504
Clazinase customer specific
Proprietary knowledge of customer.

66. In § 866.5910, revise paragraph (b) to read as follows:

§ 866.5910
Quality control material for cystic fibrosis nucleic acid assays.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.” See § 866.1(e) for the availability of this guidance document.

PART 868—ANESTHESIOLOGY DEVICES

67. The authority citation for part 868 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l,
371.

68. In § 868.1040, revise paragraph (b) to read as follows:

§ 868.1040
Powered algesimeter.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

69. In § 868.2385, revise paragraph (b) to read as follows:

§ 868.2385
Nitrogen dioxide analyzer.

(b)
Classification.
Class II (special controls). The device, when it is a standalone nitrogen dioxide analyzer and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.” See § 868.1(e) for the availability of this guidance document.

70. In § 868.2500, revise paragraph (b) to read as follows:

§ 868.2500
Cutaneous oxygen (PcO2) monitor.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.

71. In § 868.2550, revise paragraph (b) to read as follows:

§ 868.2550
Pneumotachometer.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

72. In § 868.5180, revise paragraph (b) to read as follows:

§ 868.5180
Rocking bed.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

73. In § 868.6250, revise paragraph (b) to read as follows:

§ 868.6250
Portable air compressor.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

PART 870—CARDIOVASCULAR DEVICES

74. The authority citation for part 870 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l,
371.

75. In § 870.1330, revise paragraph (b) to read as follows:

§ 870.1330
Catheter guide wire.

(b)
Classification.
Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

76. In § 870.1390, revise paragraph (b) to read as follows:

§ 870.1390
Trocar.

(b)
Classification.
Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

77. In § 870.1650, revise paragraph (b) to read as follows:

§ 870.1650
Angiographic injector and syringe.

(b)
Classification.
Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

78. In § 870.1875, revise paragraph (b)(2) to read as follows:

§ 870.1875
Stethoscope.

(b) * * *

(2)
Classification.
Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

79. In § 870.2675, revise paragraph (b) to read as follows:

§ 870.2675
Oscillometer.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

80. In § 870.2770, revise paragraph (b) to read as follows:

§ 870.2770
Impedance plethysmograph.

(b)
Classification.
Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

81. In § 870.4280, revise paragraph (b) to read as follows:

§ 870.4280
Cardiopulmonary prebypass filter.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

82. In § 870.4290, revise paragraph (b) to read as follows:

§ 870.4290
Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

83. In § 870.4340, revise paragraph (b) to read as follows:

§ 870.4340
Cardiopulmonary bypass level sensing monitor and/or control.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

84. In § 870.4400, revise paragraph (b) to read as follows:

§ 870.4400
Cardiopulmonary bypass blood reservoir.

(b)
Classification.
Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

85. In § 870.4420, revise paragraph (b) to read as follows:

§ 870.4420
Cardiopulmonary bypass cardiotomy return sucker.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

86. In § 870.4430, revise paragraph (b) to read as follows:

§ 870.4430
Cardiopulmonary bypass intracardiac suction control.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

PART 872—DENTAL DEVICES

87. The authority citation for part 872 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l,
371.

88. In § 872.1720, revise paragraph (b) to read as follows:

§ 872.1720
Pulp tester.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

89. In § 872.3260, revise paragraph (b) to read as follows:

§ 872.3260
Cavity varnish.

(b)
Classification.
Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

90. In § 872.3300, revise paragraph (b) to read as follows:

§ 872.3300
Hydrophilic resin coating for dentures.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

91. In § 872.3540, revise paragraph (b)(2) introductory text to read as follows:

§ 872.3540
OTC denture cushion or pad.

(b) * * *

(2) Class II (special controls) if the OTC denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended use of the device differs from that described in paragraph (b)(1) of this section. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's:

92. In § 872.3560, revise paragraph (b) introductory text to read as follows:

§ 872.3560
OTC denture reliner.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's:

93. In § 872.3590, revise paragraph (b) to read as follows:

§ 872.3590
Preformed plastic denture tooth.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

94. In § 872.3600, revise paragraph (b) introductory text to read as follows:

§ 872.3600
Partially fabricated denture kit.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's:

95. In § 872.3890, revise paragraph (b) to read as follows:

§ 872.3890
Endodontic stabilizing splint.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

96. In § 872.5550, revise paragraph (b)(2) to read as follows:

§ 872.5550
Teething ring.

(b) * * *

(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

97. In § 872.6770, revise paragraph (b) to read as follows:

§ 872.6770
Cartridge syringe.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

PART 874—EAR, NOSE, AND THROAT DEVICES

98. The authority citation for part 874 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l
, 371.

99. In § 874.1090, revise paragraph (b) to read as follows:

§ 874.1090
Auditory impedance tester.

(b)
Classification.
Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

100. In § 874.1120, revise paragraph (b) to read as follows:

§ 874.1120
Electronic noise generator for audiometric testing.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

101. In § 874.1325, revise paragraph (b) to read as follows:

§ 874.1325
Electroglottograph.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

102. In § 874.3310, revise paragraph (b) to read as follows:

§ 874.3310
Hearing aid calibrator and analysis system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

103. In § 874.3320, revise paragraph (b) to read as follows:

§ 874.3320
Group hearing aid or group auditory trainer.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

104. In § 874.3330, revise paragraph (b) to read as follows:

§ 874.3330
Master hearing aid.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

105. In § 874.3430, revise paragraph (b) to read as follows:

§ 874.3430
Middle ear mold.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

106. In § 874.3730, revise paragraph (b) to read as follows:

§ 874.3730
Laryngeal prosthesis (Taub design).

(b)
Classification.
Class II (special controls). The device, when it is a voice amplification device, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

PART 876—GASTROENTEROLOGY-UROLOGY DEVICES

107. The authority citation for part 876 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l
, 371.

108. In § 876.1500, revise paragraph (b)(1) to read as follows:

§ 876.1500
Endoscope and accessories.

(b) * * *

(1) Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

109. In § 876.4020, revise paragraph (b) to read as follows:

§ 876.4020
Fiberoptic light ureteral catheter.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

110. In § 876.4270, revise paragraph (b) to read as follows:

§ 876.4270
Colostomy rod.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

111. In § 876.4400, revise paragraph (b) to read as follows:

§ 876.4400
Hemorrhoidal ligator.

(b)
Classification.
Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

112. In § 876.4500, revise paragraph (b) to read as follows:

§ 876.4500
Mechanical lithotriptor.

(b)
Classification.
Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

113. In § 876.4770, revise paragraph (b) to read as follows:

§ 876.4770
Urethrotome.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

114. In § 876.5010, revise paragraph (b) to read as follows:

§ 876.5010
Biliary catheter and accessories.

(b)
Classification.
Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

115. In § 876.5025, revise paragraph (b) introductory text to read as follows:

§ 876.5025
Vibrator for climax control of premature ejaculation.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special controls for this device are:

116. In § 876.5160, revise the section heading and paragraph (b) to read as follows:

§ 876.5160
Urological clamp.

(b)
Classification.
Class I (general controls). Except when intended for internal use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

117. In § 876.5365, revise paragraph (b) to read as follows:

§ 876.5365
Esophageal dilator.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

118. In § 876.5520, revise paragraph (b)(1) to read as follows:

§ 876.5520
Urethral dilator.

(b) * * *

(1) Class II (special controls). Except when it is a mechanical urethral dilator, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

119. In § 876.5630, revise paragraph (b) to read as follows:

§ 876.5630
Peritoneal dialysis system and accessories.

(b)
Classification.
Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.

120. In § 876.5665, revise paragraph (b) to read as follows:

§ 876.5665
Water purification system for hemodialysis.

(b)
Classification.
Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

121. In § 876.5895, revise paragraph (b) to read as follows:

§ 876.5895
Ostomy irrigator.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

122. In § 876.5980, revise paragraph (b)(1) to read as follows:

§ 876.5980
Gastrointestinal tube and accessories.

(b) * * *

(1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

PART 878—GENERAL AND PLASTIC SURGERY DEVICES

123. The authority citation for part 878 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l
, 371.

124. In § 878.4370, revise paragraph (b) to read as follows:

§ 878.4370
Surgical drape and drape accessories.

(b)
Classification.
Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

125. In § 878.4495, revise paragraph (b) to read as follows:

§ 878.4495
Stainless steel suture.

(b)
Classification.
Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

126. In § 878.4580, revise paragraph (b) to read as follows:

§ 878.4580
Surgical lamp.

(b)
Classification.
Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

127. In § 878.5070, revise paragraph (b) to read as follows:

§ 878.5070
Air-handling apparatus for a surgical operating room.

(b)
Classification.
Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES

128. The authority citation for part 880 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l
, 371.

129. In § 880.5580, revise paragraph (b) introductory text to read as follows:

§ 880.5580
Acupuncture needle.

(b)
Classification.
Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:

130. In § 880.5680, revise paragraph (b) to read as follows:

§ 880.5680
Pediatric position holder.

(b)
Classification.
Class I (general controls). Except when the device is an infant positioner for prescription use in highly monitored settings or an infant sleep position holder, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. The device is exempt from the good manufacturing practice regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

131. In § 880.5780, revise paragraph (a)(2) to read as follows:

§ 880.5780
Medical support stocking.
(a) * * *

(2)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

132. In § 880.6250, revise paragraph (b) to read as follows:

§ 880.6250
Non-powdered patient examination glove.

(b)
Classification.
Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

133. In § 880.6375, revise paragraph (b) to read as follows:

§ 880.6375
Patient lubricant.

(b)
Classification.
Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

134. In § 880.6760, revise paragraph (b) to read as follows:

§ 880.6760
Protective restraint.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

PART 882—NEUROLOGICAL DEVICES

135. The authority citation for part 882 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l
, 371.

136. In § 882.1020, revise paragraph (b) to read as follows:

§ 882.1020
Rigidity analyzer.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

137. In § 882.1030, revise paragraph (b) to read as follows:

§ 882.1030
Ataxiagraph.

(b)
Classification.
Class I (general controls). Except when the device is intended to provide an interpretation or a clinical implication of the measurement, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

138. In § 882.1470, revise paragraph (b) introductory text to read as follows:

§ 882.1470
Computerized cognitive assessment aid.

(b)
Classification.
Class II (special controls). Except when the computerized cognitive assessment aid is intended for diagnostic assessment of specific diseases or conditions and relies on inputs from visual cues, auditory cues, and/or functional use of the hand, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The special control(s) for this device are:

139. In § 882.1540, revise paragraph (b) to read as follows:

§ 882.1540
Galvanic skin response measurement device.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

140. In § 882.1560, revise paragraph (b) to read as follows:

§ 882.1560
Skin potential measurement device.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

141. In § 882.1855, revise paragraph (b) to read as follows:

§ 882.1855
Electroencephalogram (EEG) telemetry system.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

142. In § 882.4060, revise paragraph (b) to read as follows:

§ 882.4060
Ventricular cannula.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

143. In § 882.4545, revise paragraph (b) to read as follows:

§ 882.4545
Shunt system implantation instrument.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

144. In § 882.5895, revise paragraph (b) introductory text to read as follows:

§ 882.5895
Vibratory counter-stimulation device.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The special controls for this device are:

PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES

145. The authority citation for part 884 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l
, 371.

146. In § 884.1630, revise paragraph (b) to read as follows:

§ 884.1630
Colposcope.

(b)
Classification.
Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

147. In § 884.2990, revise paragraph (b) to read as follows:

§ 884.2990
Breast lesion documentation system.

(b)
Classification.
Class II (special controls). The device, when it is a breast examination recording sheet, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breast Lesion Documentation System.” See § 884.1(e) for the availability of this guidance document.

148. In § 884.3200, revise paragraph (b) to read as follows:

§ 884.3200
Cervical drain.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

149. In § 884.4400, revise paragraph (b) to read as follows:

§ 884.4400
Obstetric forceps.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

150. In § 884.4530, revise paragraph (b)(1) to read as follows:

§ 884.4530
Obstetric-gynecologic specialized manual instrument.

(b) * * *

(1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

151. In § 884.4900, revise paragraph (b) to read as follows:

§ 884.4900
Obstetric table and accessories.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

152. In § 884.5200, revise paragraph (b) introductory text to read as follows:

§ 884.5200
Hemorrhoid prevention pressure wedge.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special controls for this device are:

153. In § 884.5390, revise paragraph (b) to read as follows:

§ 884.5390
Perineal heater.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

154. In § 884.5400, revise paragraph (b) to read as follows:

§ 884.5400
Menstrual cup.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

155. In § 884.5425, revise paragraph (b)(2) to read as follows:

§ 884.5425
Scented or scented deodorized menstrual pad.

(b) * * *

(2) Class II (special controls) for scented or scented deodorized menstrual pads made of materials not described in paragraph (b)(1). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

156. In § 884.5435, revise paragraph (b) to read as follows:

§ 884.5435
Unscented menstrual pad.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9 only when the device is made of common cellulosic and synthetic material with an established safety profile.

157. In § 884.6120, revise paragraph (b) to read as follows:

§ 884.6120
Assisted reproduction accessories.

(b)
Classification.
Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; or a controlled-rate cryopreservation freezer, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

158. In § 884.6130, revise paragraph (b) to read as follows:

§ 884.6130
Assisted reproduction microtools.

(b)
Classification.
Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

159. In § 884.6150, revise paragraph (b) to read as follows:

§ 884.6150
Assisted reproduction micromanipulators and microinjectors.

(b)
Classification.
Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

160. In § 884.6160, revise paragraph (b) to read as follows:

§ 884.6160
Assisted reproduction labware.

(b)
Classification.
Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when

it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

PART 886—OPHTHALMIC DEVICES

161. The authority citation for part 886 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l
, 371.

162. In § 886.1120, revise paragraph (b) to read as follows:

§ 886.1120
Ophthalmic camera.

(b)
Classification.
Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

163. In § 886.1250, revise paragraph (b) to read as follows:

§ 886.1250
Euthyscope.

(b)
Classification.
(1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

164. In § 886.1570, revise paragraph (b) to read as follows:

§ 886.1570
Ophthalmoscope.

(b)
Classification.
Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

165. In § 886.1780, revise paragraph (b)(1) to read as follows:

§ 886.1780
Retinoscope.

(b) * * *

(1) Class II (special controls) for the AC-powered device. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

166. In § 886.1850, revise paragraph (b) to read as follows:

§ 886.1850
AC-powered slitlamp biomicroscope.

(b)
Classification.
Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

167. In § 886.1945, revise paragraph (b) to read as follows:

§ 886.1945
Transilluminator.

(b)
Classification.
(1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

168. In § 886.3320, revise paragraph (b) to read as follows:

§ 886.3320
Eye sphere implant.

(b)
Classification.
Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

169. In § 886.4070, revise paragraph (b) to read as follows:

§ 886.4070
Powered corneal burr.

(b)
Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

170. In § 886.4150, revise paragraph (b) to read as follows:

§ 886.4150
Vitreous aspiration and cutting instrument.

(b)
Classification.
Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

171. In § 886.4250, revise paragraph (b) to read as follows:

§ 886.4250
Ophthalmic electrolysis unit.

(b)
Classification.
(1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

172. In § 886.4335, revise paragraph (b) to read as follows:

§ 886.4335
Operating headlamp.

(b)
Classification.
(1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

173. In § 886.4400, revise paragraph (b) to read as follows:

§ 886.4400
Electronic metal locator.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

174. In § 886.4440, revise paragraph (b) to read as follows:

§ 886.4440
AC-powered magnet.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

175. In § 886.4790, revise paragraph (b) to read as follows:

§ 886.4790
Ophthalmic sponge.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

PART 888—ORTHOPEDIC DEVICES

176. The authority citation for part 888 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l
, 371.

177. In § 888.1240, revise paragraph (b) to read as follows:

§ 888.1240
AC-powered dynamometer.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.

178. In § 888.4580, revise paragraph (b) to read as follows:

§ 888.4580
Sonic surgical instrument and accessories/attachments.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.

PART 890—PHYSICAL MEDICINE DEVICES

179. The authority citation for part 890 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l
, 371.

180. In § 890.1450, revise paragraph (b) to read as follows:

§ 890.1450
Powered reflex hammer.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

181. In § 890.5100, revise paragraph (b) to read as follows:

§ 890.5100
Immersion hydrobath.

(b)
Classification.
Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

182. In § 890.5110, revise paragraph (b) to read as follows:

§ 890.5110
Paraffin bath.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

183. In § 890.5250, revise paragraph (b) to read as follows:

§ 890.5250
Moist steam cabinet.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

184. In § 890.5360, revise paragraph (b) to read as follows:

§ 890.5360
Measuring exercise equipment.

(b)
Classification.
Class II (special controls). The device, when it is a measuring exerciser, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

185. In § 890.5500, revise paragraph (b) to read as follows:

§ 890.5500
Infrared lamp.

(b)
Classification.
Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

186. In § 890.5575, revise paragraph (b) to read as follows:

§ 890.5575
Powered external limb overload warning device.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

PART 892—RADIOLOGY DEVICES

187. The authority citation for part 892 continues to read as follows:

Authority:

21 U.S.C. 351, 360, 360c, 360e, 360j, 360
l
, 371.

188. In § 892.1000, revise paragraph (b) to read as follows:

§ 892.1000
Magnetic resonance diagnostic device.

(b)
Classification.
Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

189. In § 892.1560, revise paragraph (b) to read as follows:

§ 892.1560
Ultrasonic pulsed echo imaging system.

(b)
Classification.
Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

190. In § 892.1610, revise paragraph (b) to read as follows:

§ 892.1610
Diagnostic x-ray beam-limiting device.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

191. In § 892.1650, revise paragraph (b) to read as follows:

§ 892.1650
Image-intensified fluoroscopic x-ray system.

(b)
Classification.
Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

192. In § 892.1670, revise paragraph (b) to read as follows:

§ 892.1670
Spot-film device.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

193. In § 892.1680, revise paragraph (b) to read as follows:

§ 892.1680
Stationary x-ray system.

(b)
Classification.
Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of

part 807 of this chapter subject to the limitations in § 892.9.

194. In § 892.1730, revise paragraph (b) to read as follows:

§ 892.1730
Photofluorographic x-ray system.

(b)
Classification.
Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

195. In § 892.1820, revise paragraph (b) to read as follows:

§ 892.1820
Pneumoencephalographic chair.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

196. In § 892.1850, revise paragraph (b) to read as follows:

§ 892.1850
Radiographic film cassette.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

197. In § 892.1860, revise paragraph (b) to read as follows:

§ 892.1860
Radiographic film/cassette changer.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

198. In § 892.1870, revise paragraph (b) to read as follows:

§ 892.1870
Radiographic film/cassette changer programmer.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

199. In § 892.1900, revise paragraph (b) to read as follows:

§ 892.1900
Automatic radiographic film processor.

(b)
Classification.
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

200. In § 892.2030, revise paragraph (b) to read as follows:

§ 892.2030
Medical image digitizer.

(b)
Classification.
Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2019-27394. Public record. Not legal advice.