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

DIF — Predicate Candidate Screening

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

37 daysmedian FDA review time

110 days90th percentile

202clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K153474	Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Li	Biochemical Diagnostics, Inc.	2016-02-23	83	0
K132688	SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL	Biochemical Diagnostics, Inc.	2013-12-16	110	0
K132174	MULTICHEM WBT	Techno-Path Manufacturing , Ltd.	2013-09-20	67	0
K121122	DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID C	Biochemical Diagnostic, Inc.	2012-07-03	81	0
K121143	LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2	Bio-Rad Laboratories	2012-05-18	32	0
K120504	LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUI	Bio-Rad Laboratories, Inc.	2012-03-27	35	0
K103656	THERMO SCIENTIFIC MAS R DOA TOTAL	Microgenics Corporation	2011-03-24	99	0
K093577	LIQUICHEK OPIATE CONTROL	Bio-Rad Laboratories	2010-03-12	114	0
K080085	MAS TOX CONTROL	Thermo Fisher Scientific	2008-04-30	110	0
K080183	CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, C	Roche Diagnostics Corp.	2008-03-25	60	0
K072721	LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMM	Bio-Rad, Diagnostics Grp.	2007-12-11	76	0
K063398	ESA LEADCARE II LEAD CONTROL	Bionostics, Inc.	2006-12-05	26	0
K062191	DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE	Dade Behring, Inc.	2006-08-21	21	0
K060788	TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL	Biosite Incorporated	2006-07-10	109	1
K060417	MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL	Quantimetrix Corp.	2006-03-21	32	0
K052053	LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, PO	Bio-Rad	2005-08-09	11	0
K050682	LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)	Bio-Rad Laboratories, Inc.	2005-04-29	44	0
K050037	TRIAGE TOX DRUG SCREEN CONTROLS	Biosite Incorporated	2005-03-22	74	0
K042865	LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)	Bio-Rad	2004-11-24	37	0
K041666	DC-ACETA/SAL CONTROLS	Diagnostic Chemicals , Ltd.	2004-08-17	60	0
K041561	LIQUICHEK WHOLE BLOOD VOLATILES CONTROL	Bio-Rad	2004-07-06	26	0
K040758	MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT	Microgenics Corp.	2004-05-28	64	0
K033924	LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)	Bio-Rad Laboratories, Inc.	2004-02-03	47	0
K033366	LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MO	Bio-Rad	2003-12-12	52	0
K033404	LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)	Bio-Rad	2003-12-12	49	0
K032826	MAS PAR TDM	Medical Analysis Systems, Inc.	2003-10-09	29	0
K022707	LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEV	Bio-Rad	2002-08-22	8	0
K021414	LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2	Bio-Rad	2002-05-29	26	0
K021411	LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS	Bio-Rad	2002-05-29	26	0
K021384	LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,	Bio-Rad	2002-05-29	27	0
K021415	LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3	Bio-Rad	2002-05-29	26	0
K012999	TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001	Biosite Incorporated	2001-10-03	27	0
K013002	TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CA	Biosite Incorporated	2001-10-03	27	0
K012907	LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL	Clinical Controls	2001-09-28	30	0
K012741	LIQUICHEK TDM CONTROL	Bio-Rad	2001-09-12	27	0
K012319	RANDOX HUMAN ASSSAYED DRUG CONTROL	Randox Laboratories, Ltd.	2001-08-24	32	0
K992395	URINE DRUG SCREENING CONTROL	Seracare Technology	1999-08-26	38	0
K990377	ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MOD	Roche Diagnostics Corp.	1999-02-26	18	0
K983709	SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1	Beckman Coulter, Inc.	1998-10-28	7	0
K983387	ONTRAK TESTCUP AND TESTSTIK CONTROLS	Roche Diagnostic Systems, Inc.	1998-10-09	14	0
K983127	OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2	Medical Analysis Systems, Inc.	1998-09-14	6	0
K982649	VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, A	Ortho-Clinical Diagnostics, Inc.	1998-08-12	13	0
K982217	AC/AD LINEARITY VERIFIERS	Sc Calibrators & Controls, LLC	1998-07-02	8	0
K982024	OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2	Medical Analysis Systems, Inc.	1998-06-29	20	0
K981590	LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE	Bio-Rad	1998-06-10	37	0
K980871	LYPHOCHEK WHOLE BLOOD CONTROL	Bio-Rad	1998-04-06	46	0
K980331	IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMU	More Diagnostics	1998-03-16	47	0
K972819	VIGIL TDM CONTROLS	Beckman Instruments, Inc.	1997-08-13	15	0
K971060	PRECINORM TDM CONTROLS	Boehringer Mannheim Corp.	1997-07-07	105	0
K972174	LYPHOCHEK REMEDI CONTROL	Bio-Rad	1997-06-24	15	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