Test, Cannabinoid, Employment And Insurance Testing, Exempt
The Test, Cannabinoid, Employment And Insurance Testing (Exempt) is a clinical toxicology in vitro diagnostic test for the qualitative analysis of cannabinoids (including THC metabolites), intended for use in workplace and insurance drug screening programs rather than clinical diagnosis. It is classified as FDA Class II under regulation 21 CFR 862.3870 and has been exempted from 510(k) premarket notification requirements by FDA Federal Register publication (82 FR 31976, July 11, 2017), subject to the limitations in 21 CFR 862.9. The product code is PVJ and it falls under the Clinical Toxicology medical specialty. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PVJ
- Device Class
- FDA class 2
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
Definition
The cannabinoid test is an in vitro diagnostic test for the qualitative analysis of cannabinoids for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturers device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing.
FEI Numbers
This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.