Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LAT — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
61 daysmedian FDA review time
360 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011426 | PSYCHEMEDICS RIA CANNABINOID ASSAY | Psychemedics Corp. | 2002-05-03 | 360 | 0 |
| K961620 | ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 | Roche Diagnostic Systems, Inc. | 1996-06-13 | 48 | 0 |
| K936135 | SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MA | Sudormed, Inc. | 1996-06-10 | 895 | 0 |
| K914507 | DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE | Diagnostic Products Corp. | 1991-12-18 | 70 | 0 |
| K913414 | ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT | Roche Diagnostic Systems, Inc. | 1991-09-25 | 62 | 0 |
| K913865 | URINE THC DIRECT RIA KIT (I-125) | Immunalysis Corporation | 1991-09-18 | 22 | 0 |
| K912574 | ABUSCREEN ONLINE FOR THC (50 AND 100) | Roche Diagnostic Systems, Inc. | 1991-08-12 | 61 | 0 |
| K904996 | ABUSCREEN ONLINE TM FOR THC | Roche Diagnostic Systems, Inc. | 1991-01-11 | 65 | 0 |
| K843534 | ORAL THC-CANNABINOIDS DIRECT RIA KIT | Immunalysis Corporation | 1984-10-30 | 53 | 0 |
| K833911 | URINE THC CANNABINOIDS DIRECT RIA KIT | Immunalysis Corporation | 1984-01-24 | 71 | 0 |
| K821965 | ORAL THC-CANNABINOIDS DIRECT RIA KIT | Immunalysis Corporation | 1982-07-20 | 18 | 0 |
| K820903 | THC-CANNABINOIDS DIRECT URINE RIA KIT | Immunalysis Corporation | 1982-05-05 | 35 | 0 |
| K820391 | ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI | Hoffmann-La Roche, Inc. | 1982-03-08 | 26 | 0 |
| K800246 | EMIT -D.A.U. CANNABINOID URINE ASSAY | Syva Co. | 1980-02-26 | 21 | 0 |
| K791649 | TETRAHYDROCANNALBINOL DIRECT BLOOD KIT | Immunalysis Corporation | 1979-10-11 | 48 | 0 |
| K781048 | THC DIRECT RIA KIT | Immunalysis Corporation | 1978-10-03 | 104 | 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