Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

DOE — Predicate Candidate Screening

12 FDA 510(k) clearances under this product code; the 50 most recent screened below.

139 daysmedian FDA review time

257 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K010079	INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST	Alfa Scientific Designs, Inc.	2001-05-29	139
K010080	INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST	Alfa Scientific Designs, Inc.	2001-05-29	139
K011011	LIVESURE MORPHINE SCREEN TEST	Pan Probe Biotech, Inc.	2001-04-13	9
K002418	BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN	Branan Medical Corporation	2000-11-22	106
K951319	ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML	Roche Diagnostic Systems, Inc.	1995-06-01	70
K935055	ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)	Roche Diagnostic Systems, Inc.	1994-08-09	293
K933572	URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)	Immunalysis Corporation	1994-04-06	257
K881102	MICROMEDIC MORPHINE RIA KIT	Icn Micromedic Systems	1988-06-24	101
K863913	THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT	Diagnostic Products Corp.	1987-03-19	162
K864168	MORPHINE ROCHE (R) EIA TEST	Roche Diagnostic Systems, Inc.	1987-03-16	143
K830462	ABUSCREEN RADIOUMMUNOASSAY--URINE	Hoffmann-La Roche, Inc.	1983-03-24	37
K830460	ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE	Hoffmann-La Roche, Inc.	1983-03-24	37

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