Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KLN — Predicate Candidate Screening

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

37 daysmedian FDA review time

228 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K010868	PSYCHEMEDICS RIA COCAINE ASSAY	Psychemedics Corp.	2001-11-06	228
K913867	URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)	Immunalysis Corporation	1991-09-19	23
K913722	ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE	Roche Diagnostic Systems, Inc.	1991-09-10	25
K912756	ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE	Roche Diagnostic Systems, Inc.	1991-07-26	35
K910122	TARGET COCAINE METABOLITE-R	V-Tech, Inc.	1991-03-19	67
K910123	TARGET COCAINE METABOLITE-V	V-Tech, Inc.	1991-03-19	67
K910044	MILENIA COCAINE METABOLITE	Diagnostic Products Corp.	1991-02-13	40
K905730	ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)	Roche Diagnostic Systems, Inc.	1991-01-15	22
K904995	ABUSCREEN ONLINE TM FOR COCAINE METABOLITE	Roche Diagnostic Systems, Inc.	1990-11-28	21
K880674	MICROMEDIC CRACKPOT RIA KIT	Icn Micromedic Systems	1988-10-06	230
K871549	RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]	Immunalysis Corporation	1987-06-16	63
K870740	COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5	Diagnostic Products Corp.	1987-03-19	22
K862218	DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT	Diagnostic Products Corp.	1986-06-27	16
K830480	ABUSCREEN RADIOIMMUNOASSAY-COCAINE META	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