FDA product code DIT: Thin Layer Chromatography, Amphetamine
DIT is the FDA product code for thin layer chromatography, amphetamine. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under DIT, from 4 different applicants. The average 510(k) review took 44 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Amphetamine |
| Device class | Class II |
| Regulation | 21 CFR 862.3100 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top DIT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Phamatech | 1 | 1997-08-20 |
| Drug Screening Systems, Inc. | 1 | 1991-04-05 |
| Diagnostic Products Corp. | 1 | 1990-04-26 |
| Technical Resources, Inc. | 1 | 1979-06-06 |
Most recent DIT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972577 | Phamatech | QUICK SCREEN ONE STEP AMPHETAMINE TEST | 1997-08-20 | 41 |
| K910525 | Drug Screening Systems, Inc. | MICROLINE SCREEN FOR METHAMPHETAMINE | 1991-04-05 | 57 |
| K901276 | Diagnostic Products Corp. | HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL | 1990-04-26 | 38 |
| K790805 | Technical Resources, Inc. | DRUG ABUSE DIPSTICKS | 1979-06-06 | 42 |
Recalls for DIT devices
openFDA lists no recalls for product code DIT.
Frequently asked questions
What is FDA product code DIT?
DIT is the FDA product code for thin layer chromatography, amphetamine. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel.
What device class is DIT?
Class II, regulation 21 CFR 862.3100. Typical premarket route: 510(k).
How long does a 510(k) take for product code DIT?
Across 4 cleared submissions the average was 44 days from receipt to decision (median 42).
Which companies have the most DIT clearances?
Phamatech (1); Drug Screening Systems, Inc. (1); Diagnostic Products Corp. (1); Technical Resources, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DIT
- Run a recall and safety report across every DIT manufacturer
- Watch product code DIT 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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