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
Cleared
Dec 11, 2024
Alinity c Benzodiazepines Reagent Kit
Microgenics Corporation
Toxicology
29d
Cleared
Dec 23, 2022
ONLINE DAT Benzodiazepines II
Roche Diagnostics
Toxicology
189d
Cleared
Dec 09, 2019
CEDIA Benzodiazepine Assay
Microgenics Corporation
Toxicology
241d
Cleared
Feb 21, 2018
DRI Benzodiazepine Assay
Microgenics Corporation
Toxicology
55d
Cleared
Aug 02, 2017
Healgen Multi-Drug Urine Test Cup
Healgen Scientific, LLC
Toxicology
216d
Cleared
May 23, 2016
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
Healgen Scientific, LLC
Toxicology
159d
Cleared
Jan 05, 2016
Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
Immunalysis Corporation
Toxicology
189d
Cleared
Jun 13, 2005
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
Beckman Coulter, Inc.
Chemistry
25d
Cleared
Mar 28, 2005
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
Beckman Coulter, Inc.
Chemistry
91d
Cleared
Feb 07, 2005
ONLINE DAT BENZODIAZEPINES PLUS
Roche Diagnostics Corp.
Toxicology
67d
Cleared
Nov 07, 2002
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
Beckman Coulter, Inc.
Toxicology
55d
Cleared
Mar 13, 2002
BENZODIAZEPINES
Abbott Laboratories
Toxicology
174d
Cleared
Apr 17, 2000
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
Dade Behring, Inc.
Toxicology
66d
Cleared
Jan 27, 2000
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
Syva Co.
Toxicology
64d
Cleared
Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
Roche Diagnostics Corp.
Toxicology
57d
Cleared
Feb 11, 1999
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
Roche Diagnostic Systems, Inc.
Toxicology
113d
Cleared
Nov 18, 1998
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
Roche Diagnostic Systems, Inc.
Toxicology
69d
Cleared
Dec 10, 1996
CEDIA DAU BENZODIAZEPINE ASSAY
Boehringer Mannheim Corp.
Toxicology
148d
Cleared
May 16, 1995
AXSYM BENZODIAZEPINES
Abbott Laboratories
Toxicology
56d
Cleared
May 16, 1995
AXSYM CANNABINOIDS
Abbott Laboratories
Toxicology
56d
Cleared
Mar 21, 1995
URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE
E.I. Dupont DE Nemours & Co., Inc.
Toxicology
47d
Cleared
Nov 21, 1994
CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS
Beckman Instruments, Inc.
Toxicology
139d
Cleared
May 11, 1993
EMIT(R) D.A.U. BENZODIAZEPINE ASSAY
Syva Co.
Toxicology
43d
Cleared
Jan 12, 1993
EMIT(R) II BENZODIAZEPINE ASSAY
Syva Co.
Toxicology
42d
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 →