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 Nov 18, 1998
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
K983174
Roche Diagnostic Systems, Inc.
Toxicology · 69d
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 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 Jun 20, 1995
CEDIA DAU BENZODIAZEPINE ASSAY
K951710
Microgenics Corp.
Toxicology · 67d
Cleared May 16, 1995
AXSYM BENZODIAZEPINES
K951286
Abbott Laboratories
Toxicology · 56d
Cleared May 16, 1995
AXSYM CANNABINOIDS
K951288
Abbott Laboratories
Toxicology · 56d
Cleared Mar 21, 1995
URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE
K950427
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 47d
Cleared Nov 21, 1994
CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS
K944076
Beckman Instruments, Inc.
Toxicology · 139d
Cleared Aug 01, 1994
CEDIA DAU BENZODIAZEPINE ASSAY
K942795
Microgenics Corp.
Toxicology · 54d
Cleared May 27, 1994
CEDIA DAU BENZODIAZEPINE ASSAY
K940159
Microgenics Corp.
Toxicology · 135d
Cleared Aug 05, 1993
BENZODIAZEPINE ENZYME IMMUNOASSAY
K930529
Diagnostic Reagents, Inc.
Toxicology · 184d
Cleared May 11, 1993
EMIT(R) D.A.U. BENZODIAZEPINE ASSAY
K931536
Syva Co.
Toxicology · 43d
Cleared Jan 12, 1993
EMIT(R) II BENZODIAZEPINE ASSAY
K926067
Syva Co.
Toxicology · 42d
Cleared Feb 18, 1992
EMIT D.A.U BENZODIAZEPINE ASSAY
K915501
Syva Co.
Toxicology · 71d
Cleared Jan 27, 1992
IL TEST(TM) BENZODIAZEPINE
K914815
Instrumentation Laboratory CO
Chemistry · 94d
Cleared Nov 01, 1991
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES
K914509
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Apr 05, 1991
ABUSCREEN ONTRAK FOR BENZODIAZEPINE
K910590
Roche Diagnostic Systems, Inc.
Toxicology · 52d
Cleared Feb 22, 1991
EMIT II BENZODIAZEPINE ASSAY
K910376
Syva Co.
Toxicology · 24d
Cleared Mar 23, 1990
MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
K896780
Immunotech Corp.
Toxicology · 109d