FDA product code DJC: Thin Layer Chromatography, Methamphetamine
DJC is the FDA product code for thin layer chromatography, methamphetamine. It is a Class II device, regulated under 21 CFR 862.3610 and reviewed by the Clinical Toxicology panel. FDA has cleared 31 510(k) submissions under DJC, 2 in the last five years, from 23 different applicants. The average 510(k) review took 133 days (median 107); 262 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Methamphetamine |
| Device class | Class II |
| Regulation | 21 CFR 862.3610 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DJC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 3 | 217 |
| 2025 | 1 | 411 |
| 2026 | 1 | 112 |
Compare with all 510(k) review times · Search every DJC clearance
Top DJC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alfa Scientific Designs, Inc. | 3 | 2002-11-13 |
| Premier Biotech, Inc. | 2 | 2018-09-20 |
| Acro Biotech, LLC | 2 | 2006-08-07 |
| Medtox Diagnostics, Inc. | 2 | 2002-07-30 |
| Branan Medical Corporation | 2 | 2000-11-27 |
18 more applicants have DJC clearances. See the full list in Caduvo.
Most recent DJC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253705 | Healgen Scientific,, LLC | Healgen® Accurate Oral Fluid Drug Test | 2026-03-16 | 112 |
| K240287 | Hangzhou Laihe Biotech Co., Ltd. | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | 2025-03-18 | 411 |
| K180878 | Shanghai Venture Bio-Tech Co., Ltd. | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx | 2018-12-17 | 258 |
| K181305 | Premier Biotech, Inc. | OralTox Oral fluid Drug Test | 2018-09-20 | 126 |
| K171403 | Premier Biotech, Inc. | OralTox Oral Fluid Drug Test | 2018-02-02 | 266 |
Recalls for DJC devices
openFDA lists no recalls for product code DJC.
Frequently asked questions
What is FDA product code DJC?
DJC is the FDA product code for thin layer chromatography, methamphetamine. It is a Class II device, regulated under 21 CFR 862.3610 and reviewed by the Clinical Toxicology panel.
What device class is DJC?
Class II, regulation 21 CFR 862.3610. Typical premarket route: 510(k).
How long does a 510(k) take for product code DJC?
Across 31 cleared submissions the average was 133 days from receipt to decision (median 107).
Which companies have the most DJC clearances?
Alfa Scientific Designs, Inc. (3); Premier Biotech, Inc. (2); Acro Biotech, LLC (2); Medtox Diagnostics, Inc. (2); Branan Medical Corporation (2).
Next steps
- Run an FDA pathway report with predicate devices for product code DJC
- Run a recall and safety report across every DJC manufacturer
- Watch product code DJC 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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