FDA product code DJP: Radioimmunoassay, Amphetamine
DJP is the FDA product code for radioimmunoassay, amphetamine. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel. FDA has cleared 9 510(k) submissions under DJP, from 5 different applicants. The average 510(k) review took 53 days (median 41).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, 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 |
Compare with all 510(k) review times · Search every DJP clearance
Top DJP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 3 | 1991-08-26 |
| Hoffmann-La Roche, Inc. | 3 | 1983-03-24 |
| Diagnostic Reagents, Inc. | 1 | 1996-03-18 |
| Immunalysis Corporation | 1 | 1991-09-25 |
| Diagnostic Products Corp. | 1 | 1988-08-08 |
Most recent DJP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960526 | Diagnostic Reagents, Inc. | PRIMIDONE EIA TEST | 1996-03-18 | 41 |
| K913866 | Immunalysis Corporation | URINE AMPHETAMINE DIRECT RIA KIT (I-125) | 1991-09-25 | 29 |
| K912755 | Roche Diagnostic Systems, Inc. | ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE | 1991-08-26 | 66 |
| K882228 | Diagnostic Products Corp. | REVISED DOUBLE ANTIBODY AMPHETAMINE | 1988-08-08 | 81 |
| K881817 | Roche Diagnostic Systems, Inc. | ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES | 1988-07-29 | 92 |
Recalls for DJP devices
openFDA lists no recalls for product code DJP.
Frequently asked questions
What is FDA product code DJP?
DJP is the FDA product code for radioimmunoassay, amphetamine. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel.
What device class is DJP?
Class II, regulation 21 CFR 862.3100. Typical premarket route: 510(k).
How long does a 510(k) take for product code DJP?
Across 9 cleared submissions the average was 53 days from receipt to decision (median 41).
Which companies have the most DJP clearances?
Roche Diagnostic Systems, Inc. (3); Hoffmann-La Roche, Inc. (3); Diagnostic Reagents, Inc. (1); Immunalysis Corporation (1); Diagnostic Products Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DJP
- Run a recall and safety report across every DJP manufacturer
- Watch product code DJP 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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