FDA product code DKE: Reagents, Test, Tetrahydrocannabinol
DKE is the FDA product code for reagents, test, tetrahydrocannabinol. It is a Class II device, regulated under 21 CFR 862.3870 and reviewed by the Clinical Toxicology panel. FDA has cleared 12 510(k) submissions under DKE, from 7 different applicants. The average 510(k) review took 65 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Reagents, Test, Tetrahydrocannabinol |
| Device class | Class II |
| Regulation | 21 CFR 862.3870 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DKE clearance
Top DKE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Princeton BioMeditech Corp. | 4 | 1999-07-06 |
| Medtox Diagnostics, Inc. | 2 | 2000-12-22 |
| Marion Laboratories, Inc. | 2 | 1988-07-05 |
| Alfa Scientific Designs, Inc. | 1 | 2000-06-02 |
| Toxi-Lab, Inc. | 1 | 1990-06-01 |
2 more applicants have DKE clearances. See the full list in Caduvo.
Most recent DKE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K003687 | Medtox Diagnostics, Inc. | VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC | 2000-12-22 | 22 |
| K994405 | Alfa Scientific Designs, Inc. | INSTANT-VIEW MARIJUANA URINE CASSETTE TEST | 2000-06-02 | 157 |
| K992068 | Princeton BioMeditech Corp. | STATUS STIK, ACCUSIGN STIK | 1999-07-06 | 18 |
| K991751 | Princeton BioMeditech Corp. | STATUS CUP ACCUSIGN CUP | 1999-06-18 | 25 |
| K991078 | Princeton BioMeditech Corp. | 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 | 1999-04-15 | 20 |
Recalls for DKE devices
openFDA lists no recalls for product code DKE.
Frequently asked questions
What is FDA product code DKE?
DKE is the FDA product code for reagents, test, tetrahydrocannabinol. It is a Class II device, regulated under 21 CFR 862.3870 and reviewed by the Clinical Toxicology panel.
What device class is DKE?
Class II, regulation 21 CFR 862.3870. Typical premarket route: 510(k).
How long does a 510(k) take for product code DKE?
Across 12 cleared submissions the average was 65 days from receipt to decision (median 44).
Which companies have the most DKE clearances?
Princeton BioMeditech Corp. (4); Medtox Diagnostics, Inc. (2); Marion Laboratories, Inc. (2); Alfa Scientific Designs, Inc. (1); Toxi-Lab, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DKE
- Run a recall and safety report across every DKE manufacturer
- Watch product code DKE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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