Product Code: JXM FDA class 2 21 CFR 862.3170

Enzyme Immunoassay, Benzodiazepine

Clinical Toxicology

Enzyme Immunoassay, Benzodiazepine is an in vitro diagnostic test device that uses enzyme immunoassay methodology to detect and quantify benzodiazepine compounds or their metabolites in biological specimens such as urine or serum, used in toxicology screening and therapeutic drug monitoring. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is JXM, regulated under 21 CFR 862.3170, and falls within the Clinical Toxicology medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: JXM
Device Class: FDA class 2
Regulation Number: 862.3170
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 90 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243498	Alinity c Benzodiazepines Reagent Kit	Dec 11, 2024	Substantially Equivalent	Microgenics Corporation
K221765	ONLINE DAT Benzodiazepines II	Dec 23, 2022	Substantially Equivalent	Roche Diagnostics
K190968	CEDIA Benzodiazepine Assay	Dec 09, 2019	Substantially Equivalent	Microgenics Corporation
K173963	DRI Benzodiazepine Assay	Feb 21, 2018	Substantially Equivalent	Microgenics Corporation
K163590	Psychemedics Microplate EIA for Benzodiazepines in Hair	Sep 15, 2017	Substantially Equivalent	Psychemedics Corporation
K163704	Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card	Aug 02, 2017	Substantially Equivalent	Healgen Scientific,, LLC
K153597	Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card	May 23, 2016	Substantially Equivalent	Healgen Scientific,, LLC
K151771	Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators	Jan 05, 2016	Substantially Equivalent	Immunalysis Corporation
K151642	Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card	Aug 13, 2015	Substantially Equivalent	Healgen Scientific,, LLC
K150356	Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card	May 13, 2015	Substantially Equivalent	Healgen Scientific,, LLC
K123080	CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS	Nov 29, 2012	Substantially Equivalent	Chemtron Biotech, Inc.
K111322	CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD	Sep 14, 2011	Substantially Equivalent	Chemtron Biotech, Inc.
K092274	RANDOX BENZODIAZEPINE ASSAY	Oct 15, 2010	Substantially Equivalent	Randox Laboratories, Ltd.
K062285	VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV	Dec 22, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K060354	ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000	Jul 28, 2006	Substantially Equivalent	Acro Biotech, LLC
K051307	SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT	Jun 13, 2005	Substantially Equivalent	Beckman Coulter, Inc.
K050179	RANDOX BENZODIAZEPINE CLASS ASSAY	May 17, 2005	Substantially Equivalent	Randox Laboratories, Ltd.
K043556	SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT	Mar 28, 2005	Substantially Equivalent	Beckman Coulter, Inc.
K043327	ONLINE DAT BENZODIAZEPINES PLUS	Feb 07, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K043167	PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X	Dec 29, 2004	Substantially Equivalent	Phamatech, Inc.
K032365	BENZODIAZEPINE ENZYME IMMUNOASSAY	Sep 05, 2003	Substantially Equivalent	Lin-Zhi International, Inc.
K023048	MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT	Nov 07, 2002	Substantially Equivalent	Beckman Coulter, Inc.
K013882	OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I	Apr 17, 2002	Substantially Equivalent	OraSure Technologies, Inc.
K013143	BENZODIAZEPINES	Mar 13, 2002	Substantially Equivalent	Abbott Laboratories
K012300	ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE	Sep 17, 2001	Substantially Equivalent	ACON Laboratories, Inc.
K012131	LIVESURE BENZODIAZEPINES SCREEN TESTS	Jul 20, 2001	Substantially Equivalent	Pan Probe Biotech, Inc.
K003881	INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST	May 29, 2001	Substantially Equivalent	Alfa Scientific Designs, Inc.
K003879	INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)	May 29, 2001	Substantially Equivalent	Alfa Scientific Designs, Inc.
K011306	EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229	May 16, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K002342	BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST	Nov 27, 2000	Substantially Equivalent	Branan Medical Corporation
K000458	URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A	Apr 17, 2000	Substantially Equivalent	Dade Behring, Inc.
K000449	SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST	Apr 07, 2000	Substantially Equivalent	Drug Detection Devices, Ltd.
K992720	RAPIDONE- BENZODIAZEPINE TEST	Apr 03, 2000	Substantially Equivalent	American Bio Medica Corp.
K993985	SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL	Jan 27, 2000	Substantially Equivalent	Syva Co.
K991443	ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)	Jun 22, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K991079	ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO	Apr 15, 1999	Substantially Equivalent	Princeton BioMeditech Corp.
K983702	MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES	Feb 11, 1999	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K983174	ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES	Nov 18, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K982831	AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U	Nov 12, 1998	Substantially Equivalent	OraSure Technologies, Inc.
K981687	QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1	Jun 03, 1998	Substantially Equivalent	Phamatech
K980776	ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST	Apr 29, 1998	Substantially Equivalent	Tcpi, Inc.
K973269	QUIKSTRIP ONE STEP BENZODIAZEPINE TEST	Feb 25, 1998	Substantially Equivalent	Drial Consultants, Inc.
K973326	QUIKPAC II ONE STEP BENZODIAZEPINE TEST	Feb 24, 1998	Substantially Equivalent	Drial Consultants, Inc.
K974181	ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B	Dec 11, 1997	Substantially Equivalent	Princeton BioMeditech Corp.
K962734	CEDIA DAU BENZODIAZEPINE ASSAY	Dec 10, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K962672	ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY	Aug 30, 1996	Substantially Equivalent	Princeton BioMeditech Corp.
K961325	ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP	Jun 12, 1996	Substantially Equivalent	Princeton BioMeditech Corp.
K960708	BENZODIAZEPINE SERUM TOX EIA TEST	May 20, 1996	Substantially Equivalent	Diagnostic Reagents, Inc.
K954626	CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)	Nov 27, 1995	Substantially Equivalent	Microgenics Corp.
K953105	VISUALINE II BENZODIAZEPINES	Oct 05, 1995	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K951710	CEDIA DAU BENZODIAZEPINE ASSAY	Jun 20, 1995	Substantially Equivalent	Microgenics Corp.
K951288	AXSYM CANNABINOIDS	May 16, 1995	Substantially Equivalent	Abbott Laboratories
K951286	AXSYM BENZODIAZEPINES	May 16, 1995	Substantially Equivalent	Abbott Laboratories
K950427	URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE	Mar 21, 1995	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K945829	MICROLINE SCREEN FOR BENZODIAZEPINE	Jan 25, 1995	Substantially Equivalent	Drug Screening Systems, Inc.
K944076	CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS	Nov 21, 1994	Substantially Equivalent	Beckman Instruments, Inc.
K942795	CEDIA DAU BENZODIAZEPINE ASSAY	Aug 01, 1994	Substantially Equivalent	Microgenics Corp.
K940159	CEDIA DAU BENZODIAZEPINE ASSAY	May 27, 1994	Substantially Equivalent	Microgenics Corp.
K934869	STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA	Nov 22, 1993	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K930529	BENZODIAZEPINE ENZYME IMMUNOASSAY	Aug 05, 1993	Substantially Equivalent	Diagnostic Reagents, Inc.
K931536	EMIT(R) D.A.U. BENZODIAZEPINE ASSAY	May 11, 1993	Substantially Equivalent	Syva Co.
K926067	EMIT(R) II BENZODIAZEPINE ASSAY	Jan 12, 1993	Substantially Equivalent	Syva Co.
K915501	EMIT D.A.U BENZODIAZEPINE ASSAY	Feb 18, 1992	Substantially Equivalent	Syva Co.
K914815	IL TEST(TM) BENZODIAZEPINE	Jan 27, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K914509	ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES	Nov 01, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K910590	ABUSCREEN ONTRAK FOR BENZODIAZEPINE	Apr 05, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K910376	EMIT II BENZODIAZEPINE ASSAY	Feb 22, 1991	Substantially Equivalent	Syva Co.
K896780	MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT	Mar 23, 1990	Substantially Equivalent	Immunotech Corp.
K896744	BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC	Feb 23, 1990	Substantially Equivalent	Bio-Rad
K890691	ADX TM BENZODIAZEPINES	Aug 25, 1989	Substantially Equivalent	Abbott Laboratories
K891697	ABUSCREEN FP BENZODIAZEPHINE REAGENT	Mar 31, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K890001	DOUBLE ANTIBODY SERUM BENZODIAZEPINES	Jan 24, 1989	Substantially Equivalent	Diagnostic Products Corp.
K883730	TDX BENZODIAZEPINES SERUM	Nov 29, 1988	Substantially Equivalent	Abbott Laboratories
K883459	DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5	Sep 09, 1988	Substantially Equivalent	Diagnostic Products Corp.
K880014	REVISIED LABELING FOR ADX BENZODIAZEPINES	Feb 11, 1988	Substantially Equivalent	Abbott Laboratories
K874489	REVISED LABELING FOR TDX BENZODIAZEPINES	Nov 23, 1987	Substantially Equivalent	Abbott Laboratories
K874376	REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS	Nov 23, 1987	Substantially Equivalent	Syva Co.
K874265	REVISED LABELING FOR BENZODIAZEPINE TEST KIT	Nov 13, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K873538	ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD	Oct 02, 1987	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K870994	ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES	Mar 24, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K863877	BENZODIAZEPINE ENZYME IMMUNOASSAY KIT	Mar 12, 1987	Substantially Equivalent	General Diagnostics
K862250	TDX BENZODIAZEPINES	Jul 11, 1986	Substantially Equivalent	Abbott Laboratories
K851568	EMIT 700 BENZODIAZEPINE ASSAY	May 10, 1985	Substantially Equivalent	Syva Co.
K842815	EMIT D.A.U. BENZODIAZEPINE ASSAY	Sep 26, 1984	Substantially Equivalent	Syva Co.
K842387	ACA BENZODIAZEPINES SCREEN TEST PK	Aug 15, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K840236	EMIT ST SERUM BENZODIAZEPINE ASSAY	Mar 19, 1984	Substantially Equivalent	Syva Co.
K833578	MODIF. OF EMIT URINE BENZODIAZEPINE	Jan 26, 1984	Substantially Equivalent	Syva Co.
K810463	EMIT-ST SERUM BENZODIAZEPINE ASSAY	Mar 06, 1981	Substantially Equivalent	Syva Co.
K802616	EMIT-STM BENZODIAZEPINE ASSAY	Oct 31, 1980	Substantially Equivalent	Syva Co.
K790736	EMIT-TOX SERUM BENZODIAZEPINE ASSAY	Apr 26, 1979	Substantially Equivalent	Syva Co.