DKE · Reagents, Test, Tetrahydrocannabinol
Clinical Toxicology · 21 CFR 862.3870 · Class 2
Overview
| Product Code | DKE |
|---|---|
| Device Name | Reagents, Test, Tetrahydrocannabinol |
| Regulation | 21 CFR 862.3870 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.
Classification Rationale
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).
Special Controls
*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).
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K003687 | VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC | Medtox Diagnostics, Inc. | Dec 22, 2000 | SESE |
| K994405 | INSTANT-VIEW MARIJUANA URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | Jun 2, 2000 | SESE |
| K992068 | STATUS STIK, ACCUSIGN STIK | Princeton BioMeditech Corp. | Jul 6, 1999 | SESE |
| K991751 | STATUS CUP ACCUSIGN CUP | Princeton BioMeditech Corp. | Jun 18, 1999 | SESE |
| K991078 | ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8 | Princeton BioMeditech Corp. | Apr 15, 1999 | SESE |
| K983147 | ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P | Princeton BioMeditech Corp. | Sep 28, 1998 | SESE |
| K982211 | PROFILE-II MODEL 600582 | Medtox Diagnostics, Inc. | Jul 29, 1998 | SESE |
| K901694 | SPEC(TM) EXTRACTION CARTRIDGE | Toxi-Lab, Inc. | Jun 1, 1990 | SESE |
| K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN | Marion Laboratories, Inc. | Jul 5, 1988 | SESE |
| K841831 | CANNU-SKREEN-PRELIMINARY | Biochemical Diagnostic, Inc. | Jul 6, 1984 | SESE |
| K831456 | TOXI-LAB CANNABINOID THC SCREEN | Marion Laboratories, Inc. | Jun 30, 1983 | SESE |
| K792282 | DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG | California Medical Developments, Inc. | Feb 29, 1980 | SESE |
Top Applicants
- Princeton BioMeditech Corp. — 4 clearances
- Marion Laboratories, Inc. — 2 clearances
- Medtox Diagnostics, Inc. — 2 clearances
- Alfa Scientific Designs, Inc. — 1 clearance
- Biochemical Diagnostic, Inc. — 1 clearance
