Reagents, Test, Tetrahydrocannabinol
The Test Reagents for Tetrahydrocannabinol (THC) are laboratory reagents used to detect and quantify THC and its metabolites in biological specimens such as urine or blood, supporting drug of abuse screening programs and forensic toxicology. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3870 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DKE
- Device Class
- FDA class 2
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| 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 | Dec 22, 2000 | Substantially Equivalent | Medtox Diagnostics, Inc. |
| K994405 | INSTANT-VIEW MARIJUANA URINE CASSETTE TEST | Jun 02, 2000 | Substantially Equivalent | Alfa Scientific Designs, Inc. |
| K992068 | STATUS STIK, ACCUSIGN STIK | Jul 06, 1999 | Substantially Equivalent | Princeton BioMeditech Corp. |
| K991751 | STATUS CUP ACCUSIGN CUP | Jun 18, 1999 | Substantially Equivalent | Princeton BioMeditech Corp. |
| 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 | Apr 15, 1999 | Substantially Equivalent | Princeton BioMeditech Corp. |
| 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 | Sep 28, 1998 | Substantially Equivalent | Princeton BioMeditech Corp. |
| K982211 | PROFILE-II MODEL 600582 | Jul 29, 1998 | Substantially Equivalent | Medtox Diagnostics, Inc. |
| K901694 | SPEC(TM) EXTRACTION CARTRIDGE | Jun 01, 1990 | Substantially Equivalent | Toxi-Lab, Inc. |
| K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN | Jul 05, 1988 | Substantially Equivalent | Marion Laboratories, Inc. |
| K841831 | CANNU-SKREEN-PRELIMINARY | Jul 06, 1984 | Substantially Equivalent | Biochemical Diagnostic, Inc. |
| K831456 | TOXI-LAB CANNABINOID THC SCREEN | Jun 30, 1983 | Substantially Equivalent | Marion Laboratories, Inc. |
| K792282 | DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG | Feb 29, 1980 | Substantially Equivalent | California Medical Developments, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.