JXM · Class II · 21 CFR 862.3170

FDA Product Code JXM: Enzyme Immunoassay, Benzodiazepine

Benzodiazepine detection is essential in forensic toxicology, emergency medicine, and addiction treatment monitoring. FDA product code JXM covers enzyme immunoassay systems for benzodiazepine detection.

These tests use antibody-based technology to screen for benzodiazepines — including diazepam, lorazepam, and clonazepam — in urine and other biological specimens. They are widely used as initial screening tools before confirmatory chromatographic testing.

JXM devices are Class II medical devices, regulated under 21 CFR 862.3170 and reviewed by the FDA Toxicology panel.

Leading manufacturers include Syva Co., Abbott Laboratories and Roche Diagnostic Systems, Inc..

90
Total
90
Cleared
87d
Avg days
1979
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 29d recently vs 88d historically

FDA 510(k) Cleared Enzyme Immunoassay, Benzodiazepine Devices (Product Code JXM)

90 devices
1–24 of 90
Cleared Dec 11, 2024
Alinity c Benzodiazepines Reagent Kit
K243498
Microgenics Corporation
Toxicology · 29d
Cleared Dec 23, 2022
ONLINE DAT Benzodiazepines II
K221765
Roche Diagnostics
Toxicology · 189d
Cleared Dec 09, 2019
CEDIA Benzodiazepine Assay
K190968
Microgenics Corporation
Toxicology · 241d
Cleared Feb 21, 2018
DRI Benzodiazepine Assay
K173963
Microgenics Corporation
Toxicology · 55d
Cleared Aug 02, 2017
Healgen Multi-Drug Urine Test Cup
K163704
Healgen Scientific, LLC
Toxicology · 216d
Cleared May 23, 2016
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K153597
Healgen Scientific, LLC
Toxicology · 159d
Cleared Jan 05, 2016
Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K151771
Immunalysis Corporation
Toxicology · 189d
Cleared Oct 15, 2010
RANDOX BENZODIAZEPINE ASSAY
K092274
Randox Laboratories, Ltd.
Toxicology · 444d
Cleared Dec 22, 2006
VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
K062285
Ortho-Clinical Diagnostics, Inc.
Chemistry · 137d
Cleared Jun 13, 2005
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
K051307
Beckman Coulter, Inc.
Chemistry · 25d
Cleared May 17, 2005
RANDOX BENZODIAZEPINE CLASS ASSAY
K050179
Randox Laboratories, Ltd.
Toxicology · 111d
Cleared Mar 28, 2005
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
K043556
Beckman Coulter, Inc.
Chemistry · 91d
Cleared Feb 07, 2005
ONLINE DAT BENZODIAZEPINES PLUS
K043327
Roche Diagnostics Corp.
Toxicology · 67d
Cleared Sep 05, 2003
BENZODIAZEPINE ENZYME IMMUNOASSAY
K032365
Lin-Zhi International, Inc.
Toxicology · 36d
Cleared Nov 07, 2002
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
K023048
Beckman Coulter, Inc.
Toxicology · 55d
Cleared Mar 13, 2002
BENZODIAZEPINES
K013143
Abbott Laboratories
Toxicology · 174d
Cleared Sep 17, 2001
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP
K012300
ACON Laboratories, Inc.
Toxicology · 59d
Cleared May 29, 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
K003879
Alfa Scientific Designs, Inc.
Toxicology · 165d
Cleared May 29, 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST
K003881
Alfa Scientific Designs, Inc.
Toxicology · 165d
Cleared Apr 17, 2000
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000458
Dade Behring, Inc.
Toxicology · 66d
Cleared Jan 27, 2000
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
K993985
Syva Co.
Toxicology · 64d
Cleared Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
K991443
Roche Diagnostics Corp.
Toxicology · 57d
Cleared Apr 15, 1999
ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
K991079
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Feb 11, 1999
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
K983702
Roche Diagnostic Systems, Inc.
Toxicology · 113d

About Product Code JXM - Regulatory Context

510(k) Submission Activity

90 total 510(k) submissions under product code JXM since 1979, with 90 receiving FDA clearance (average review time: 87 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - JXM Product Code

Recent submissions under JXM have taken an average of 29 days to reach a decision - down from 88 days historically, suggesting improved FDA processing for this classification.

JXM devices are reviewed by the Toxicology panel. Browse all Toxicology devices →