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

LAS — Predicate Candidate Screening

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

39 daysmedian FDA review time

133 days90th percentile

83clearances measured

K-number	Device	Applicant	Decided	Review days
K080459	CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS	Chromsystems Instruments & Chemicals GmbH	2009-11-17	636
K072257	MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL	More Diagnostics	2008-01-30	170
K062942	QUANTIMETRIX NICOSURE COTININE URINE CONTROL	Quantimetrix Corp.	2006-10-30	32
K051074	MAS IMMUNOSUPPRESSANT CONTROLS	Microgenics Corp.	2005-06-06	40
K040411	DRI OXYCODONE ASSAY	Microgenics Corp.	2004-05-27	99
K032842	MICROGENICS CYCLOSPORINE CONTROL KIT	Microgenics Corp.	2003-10-17	36
K030616	CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5	Microgenics Corp.	2003-03-31	33
K992151	REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE	Consolidated Technologies, Inc.	1999-07-14	20
K970517	INNOFLUOR TOPIRAMATE CONTROL SET	Oxis Intl., Inc.	1997-05-12	90
K971210	SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS	Beckman Instruments, Inc.	1997-04-17	15
K946119	ROCHE-TDM ONLEIN(TM) CONTROLS	Roche Diagnostic Systems, Inc.	1995-02-07	54
K943048	MICROGENICS THC CONTROL SETS	Microgenics Corp.	1994-08-24	58
K930844	ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE	Roche Diagnostic Systems, Inc.	1994-01-27	343
K934145	DUPONT ACA URINE METHADONE CONTROL	E.I. Dupont DE Nemours & Co., Inc.	1993-11-09	76
K933557	REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE	Consolidated Technologies, Inc.	1993-09-10	51
K932662	CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL	More Diagnostics	1993-07-26	54
K921939	SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)	Heraeus Kulzer, Inc.	1992-07-16	83
K921141	CANNABINOID URINE CONTROLS	Diagnostic Reagents, Inc.	1992-04-17	38
K915516	ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL	Roche Diagnostic Systems, Inc.	1992-01-28	50
K913677	ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III	Analytical Control Systems, Inc.	1991-09-25	37
K913336	ABUSCREEN(R) ONLINE(TM) CONTROLS	Roche Diagnostic Systems, Inc.	1991-08-26	34
K913107	ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ	Roche Diagnostic Systems, Inc.	1991-08-12	31
K903061	UTAK LABORATORIES TOXICOLOGY CONTROL	Utak Laboratories, Inc.	1991-04-12	277
K910829	LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2	Bio-Rad	1991-04-03	35
K910689	ABUSCREEN(R) ONLINE CONTROLS	Roche Diagnostic Systems, Inc.	1991-03-11	20
K894464	ABUSCREEN POSITIVE REFERENCE CONTROLS	Roche Diagnostic Systems, Inc.	1989-08-28	39
K894463	ABUSCREEN TRI-LEVEL REFERENCE CONTROLS	Roche Diagnostic Systems, Inc.	1989-08-21	32
K893856	ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE	Roche Diagnostic Systems, Inc.	1989-08-03	70
K893858	ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC	Roche Diagnostic Systems, Inc.	1989-08-03	70
K893855	ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES	Roche Diagnostic Systems, Inc.	1989-08-03	70
K893859	ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE	Roche Diagnostic Systems, Inc.	1989-08-03	70
K893860	ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE	Roche Diagnostic Systems, Inc.	1989-08-03	70
K893857	ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE	Roche Diagnostic Systems, Inc.	1989-08-03	70
K892004	LIQUICHEK(R) SERUM ALCOHOL CONTROL; LEVELS 1,2 & 3	Bio-Rad	1989-04-21	24
K883891	DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER	E.I. Dupont DE Nemours & Co., Inc.	1988-11-29	76
K873011	QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2	Quantimetrix Medical Industries	1987-10-29	86
K872347	DIGOXIN FPIA CONTROLS	Sigma Diagnostics, Inc.	1987-07-07	20
K871567	PHENYTOIN FPIA CONTROLS	Sigma Diagnostics, Inc.	1987-07-01	70
K864456	CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3	Cala Diagnostics	1987-05-06	174
K862419	SERUM VANCOMYCIN TOXICOLOGY CONTROL	Utak Laboratories, Inc.	1986-11-13	141
K862418	BENZODIAZEPINES TOXICOLOGY CONTROL	Utak Laboratories, Inc.	1986-11-13	141
K862421	SERUM CLONAZEPAM TOXICOLOGY CONTROL	Utak Laboratories, Inc.	1986-11-05	133
K863117	HIGH PERFORMANCE CANNABINOID CONTROLS	Rapid Diagnostic Laboratories, Inc.	1986-09-25	42
K861511	EMIT CAFFEINE CONTROL	Syva / A Syntex Co.	1986-06-13	51
K843419	EMIT 700 CANNABINOID CONTROL SET	Syva Co.	1984-10-05	35
K841533	ACA TRICYCLIC ANTIDEPRESSANTS SCREEN	E.I. Dupont DE Nemours & Co., Inc.	1984-05-11	25
K831735	MAPROTILINE	Utak Laboratories, Inc.	1983-07-26	56
K831738	CAFFINE TOXICOLOGY CONTROL	Utak Laboratories, Inc.	1983-07-26	56
K831979	EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO	Syva Co.	1983-07-19	29
K831739	PENTOBARBITAL TOXICOLOGY CONTROL	Utak Laboratories, Inc.	1983-07-06	36

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