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 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 Feb 23, 1990
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC
K896744
Bio-Rad
Toxicology · 85d
Cleared Aug 25, 1989
ADX TM BENZODIAZEPINES
K890691
Abbott Laboratories
Toxicology · 192d
Cleared Mar 31, 1989
ABUSCREEN FP BENZODIAZEPHINE REAGENT
K891697
Roche Diagnostic Systems, Inc.
Toxicology · 9d
Cleared Jan 24, 1989
DOUBLE ANTIBODY SERUM BENZODIAZEPINES
K890001
Diagnostic Products Corp.
Toxicology · 21d
Cleared Nov 29, 1988
TDX BENZODIAZEPINES SERUM
K883730
Abbott Laboratories
Toxicology · 90d
Cleared Sep 09, 1988
DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5
K883459
Diagnostic Products Corp.
Toxicology · 28d
Cleared Feb 11, 1988
REVISIED LABELING FOR ADX BENZODIAZEPINES
K880014
Abbott Laboratories
Toxicology · 38d
Cleared Nov 23, 1987
REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS
K874376
Syva Co.
Toxicology · 28d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BENZODIAZEPINES
K874489
Abbott Laboratories
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR BENZODIAZEPINE TEST KIT
K874265
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Oct 02, 1987
ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD
K873538
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 31d
Cleared Mar 24, 1987
ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES
K870994
Roche Diagnostic Systems, Inc.
Toxicology · 13d
Cleared Jul 11, 1986
TDX BENZODIAZEPINES
K862250
Abbott Laboratories
Toxicology · 29d
Cleared May 10, 1985
EMIT 700 BENZODIAZEPINE ASSAY
K851568
Syva Co.
Toxicology · 24d
Cleared Sep 26, 1984
EMIT D.A.U. BENZODIAZEPINE ASSAY
K842815
Syva Co.
Toxicology · 70d
Cleared Aug 15, 1984
ACA BENZODIAZEPINES SCREEN TEST PK
K842387
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 58d
Cleared Mar 19, 1984
EMIT ST SERUM BENZODIAZEPINE ASSAY
K840236
Syva Co.
Toxicology · 59d
Cleared Jan 26, 1984
MODIF. OF EMIT URINE BENZODIAZEPINE
K833578
Syva Co.
Toxicology · 106d
Cleared Mar 06, 1981
EMIT-ST SERUM BENZODIAZEPINE ASSAY
K810463
Syva Co.
Toxicology · 11d