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
90 devices
25–48 of 90
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 May 16, 2001
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
K011306
Syva Co., Dade Behring, Inc.
Toxicology · 16d
Cleared Apr 17, 2000
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000458
Dade Behring, Inc.
Toxicology · 66d
Cleared Apr 03, 2000
RAPIDONE- BENZODIAZEPINE TEST
K992720
American Bio Medica Corp.
Toxicology · 234d
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
Cleared Nov 18, 1998
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
K983174
Roche Diagnostic Systems, Inc.
Toxicology · 69d
Cleared Nov 12, 1998
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
K982831
OraSure Technologies, Inc.
Toxicology · 93d
Cleared Jun 03, 1998
QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
K981687
Phamatech
Toxicology · 21d
Cleared Apr 29, 1998
ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST
K980776
Tcpi, Inc.
Toxicology · 58d
Cleared Feb 25, 1998
QUIKSTRIP ONE STEP BENZODIAZEPINE TEST
K973269
Drial Consultants, Inc.
Toxicology · 180d
Cleared Feb 24, 1998
QUIKPAC II ONE STEP BENZODIAZEPINE TEST
K973326
Drial Consultants, Inc.
Toxicology · 173d
Cleared Dec 11, 1997
ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B
K974181
Princeton BioMeditech Corp.
Toxicology · 35d
Cleared Dec 10, 1996
CEDIA DAU BENZODIAZEPINE ASSAY
K962734
Boehringer Mannheim Corp.
Toxicology · 148d
Cleared Aug 30, 1996
ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY
K962672
Princeton BioMeditech Corp.
Toxicology · 52d
Cleared Jun 12, 1996
ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP
K961325
Princeton BioMeditech Corp.
Toxicology · 65d
Cleared May 20, 1996
BENZODIAZEPINE SERUM TOX EIA TEST
K960708
Diagnostic Reagents, Inc.
Toxicology · 89d
Cleared Nov 27, 1995
CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)
K954626
Microgenics Corp.
Toxicology · 55d
Cleared Oct 05, 1995
VISUALINE II BENZODIAZEPINES
K953105
Sun Biomedical Laboratories, Inc.
Toxicology · 94d
Cleared Jun 20, 1995
CEDIA DAU BENZODIAZEPINE ASSAY
K951710
Microgenics Corp.
Toxicology · 67d
Cleared May 16, 1995
AXSYM BENZODIAZEPINES
K951286
Abbott Laboratories
Toxicology · 56d