Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DJP — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
92 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960526 | PRIMIDONE EIA TEST | Diagnostic Reagents, Inc. | 1996-03-18 | 41 | 0 |
| K913866 | URINE AMPHETAMINE DIRECT RIA KIT (I-125) | Immunalysis Corporation | 1991-09-25 | 29 | 0 |
| K912755 | ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE | Roche Diagnostic Systems, Inc. | 1991-08-26 | 66 | 0 |
| K882228 | REVISED DOUBLE ANTIBODY AMPHETAMINE | Diagnostic Products Corp. | 1988-08-08 | 81 | 0 |
| K881817 | ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES | Roche Diagnostic Systems, Inc. | 1988-07-29 | 92 | 0 |
| K854009 | ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP | Roche Diagnostic Systems, Inc. | 1985-10-15 | 15 | 0 |
| K830482 | ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE | Hoffmann-La Roche, Inc. | 1983-03-24 | 37 | 0 |
| K823212 | ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE | Hoffmann-La Roche, Inc. | 1982-11-29 | 32 | 0 |
| K812986 | AGGLUTEX AMPHETAMINE TEST KIT | Hoffmann-La Roche, Inc. | 1982-01-22 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda