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

JXM — Predicate Candidate Screening

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

59 daysmedian FDA review time

184 days90th percentile

90clearances measured

K-number	Device	Applicant	Decided	Review days
K243498	Alinity c Benzodiazepines Reagent Kit	Microgenics Corporation	2024-12-11	29
K221765	ONLINE DAT Benzodiazepines II	Roche Diagnostics	2022-12-23	189
K190968	CEDIA Benzodiazepine Assay	Microgenics Corporation	2019-12-09	241
K173963	DRI Benzodiazepine Assay	Microgenics Corporation	2018-02-21	55
K163590	Psychemedics Microplate EIA for Benzodiazepines in Hair	Psychemedics Corporation	2017-09-15	269
K163704	Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine	Healgen Scientific,, LLC	2017-08-02	216
K153597	Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine	Healgen Scientific,, LLC	2016-05-23	159
K151771	Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immuna	Immunalysis Corporation	2016-01-05	189
K151642	Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine T	Healgen Scientific,, LLC	2015-08-13	56
K150356	Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine	Healgen Scientific,, LLC	2015-05-13	90
K123080	CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE T	Chemtron Biotech, Inc.	2012-11-29	59
K111322	CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD	Chemtron Biotech, Inc.	2011-09-14	126
K092274	RANDOX BENZODIAZEPINE ASSAY	Randox Laboratories, Ltd.	2010-10-15	444
K062285	VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, F	Ortho-Clinical Diagnostics, Inc.	2006-12-22	137
K060354	ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZ	Acro Biotech, LLC	2006-07-28	165
K051307	SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT	Beckman Coulter, Inc.	2005-06-13	25
K050179	RANDOX BENZODIAZEPINE CLASS ASSAY	Randox Laboratories, Ltd.	2005-05-17	111
K043556	SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT	Beckman Coulter, Inc.	2005-03-28	91
K043327	ONLINE DAT BENZODIAZEPINES PLUS	Roche Diagnostics Corp.	2005-02-07	67
K043167	PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 902	Phamatech, Inc.	2004-12-29	43
K032365	BENZODIAZEPINE ENZYME IMMUNOASSAY	Lin-Zhi International, Inc.	2003-09-05	36
K023048	MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT	Beckman Coulter, Inc.	2002-11-07	55
K013882	OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I	OraSure Technologies, Inc.	2002-04-17	145
K013143	BENZODIAZEPINES	Abbott Laboratories	2002-03-13	174
K012300	ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE S	ACON Laboratories, Inc.	2001-09-17	59
K012131	LIVESURE BENZODIAZEPINES SCREEN TESTS	Pan Probe Biotech, Inc.	2001-07-20	11
K003881	INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST	Alfa Scientific Designs, Inc.	2001-05-29	165
K003879	INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)	Alfa Scientific Designs, Inc.	2001-05-29	165
K011306	EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229	Syva Co., Dade Behring, Inc.	2001-05-16	16
K002342	BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST	Branan Medical Corporation	2000-11-27	118
K000458	URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE,	Dade Behring, Inc.	2000-04-17	66
K000449	SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODI	Drug Detection Devices, Ltd.	2000-04-07	56
K992720	RAPIDONE- BENZODIAZEPINE TEST	American Bio Medica Corp.	2000-04-03	234
K993985	SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129	Syva Co.	2000-01-27	64
K991443	ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)	Roche Diagnostics Corp.	1999-06-22	57
K991079	ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO	Princeton BioMeditech Corp.	1999-04-15	20
K983702	MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES	Roche Diagnostic Systems, Inc.	1999-02-11	113
K983174	ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZOD	Roche Diagnostic Systems, Inc.	1998-11-18	69
K982831	AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U	OraSure Technologies, Inc.	1998-11-12	93
K981687	QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 902	Phamatech	1998-06-03	21
K980776	ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST	Tcpi, Inc.	1998-04-29	58
K973269	QUIKSTRIP ONE STEP BENZODIAZEPINE TEST	Drial Consultants, Inc.	1998-02-25	180
K973326	QUIKPAC II ONE STEP BENZODIAZEPINE TEST	Drial Consultants, Inc.	1998-02-24	173
K974181	ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA	Princeton BioMeditech Corp.	1997-12-11	35
K962734	CEDIA DAU BENZODIAZEPINE ASSAY	Boehringer Mannheim Corp.	1996-12-10	148
K962672	ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY	Princeton BioMeditech Corp.	1996-08-30	52
K961325	ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA	Princeton BioMeditech Corp.	1996-06-12	65
K960708	BENZODIAZEPINE SERUM TOX EIA TEST	Diagnostic Reagents, Inc.	1996-05-20	89
K954626	CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)	Microgenics Corp.	1995-11-27	55
K953105	VISUALINE II BENZODIAZEPINES	Sun Biomedical Laboratories, Inc.	1995-10-05	94

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