DJR · Class II · 21 CFR 862.3620

FDA Product Code DJR: Enzyme Immunoassay, Methadone

Methadone monitoring is essential in opioid use disorder treatment programs. FDA product code DJR covers enzyme immunoassay systems for methadone detection in biological specimens.

These tests use antibody-based technology to screen for methadone and its metabolites in urine, confirming medication adherence in opioid treatment programs and detecting illicit methadone use in forensic and clinical settings.

DJR devices are Class II medical devices, regulated under 21 CFR 862.3620 and reviewed by the FDA Toxicology panel.

Leading manufacturers include Syva Co., Lin-Zhi International, Inc. and W.H.P.M., Inc..

63
Total
63
Cleared
114d
Avg days
1984
Since
63 devices
25–48 of 63
Cleared Jul 16, 2002
COBAS INTEGRA ONLINE DAT II METHADONE II
K021512
Roche Diagnostics Corp.
Toxicology · 68d
Cleared Mar 20, 2002
METHADONE
K013001
Abbott Laboratories
Toxicology · 195d
Cleared Nov 26, 2001
LIVESURE METHADONE SCREEN TESTS
K013796
Pan Probe Biotech, Inc.
Toxicology · 11d
Cleared Nov 20, 2001
'RAPIDONE'-METHADONE TEST
K012164
American Bio Medica Corp.
Toxicology · 132d
Cleared Oct 15, 2001
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
K012595
ACON Laboratories, Inc.
Toxicology · 66d
Cleared Jul 31, 2001
METHADONE MICROPLATE EIA URINE APPLICATION
K011131
Cozart Bioscience , Ltd.
Toxicology · 109d
Cleared May 29, 2001
INSTANT-VIEW METHADONE URINE DIP STRIP TEST
K010014
Alfa Scientific Designs, Inc.
Toxicology · 147d
Cleared May 29, 2001
INSTANT-VIEW METHADONE URINE CASSETTE TEST
K010015
Alfa Scientific Designs, Inc.
Toxicology · 147d
Cleared Apr 26, 2001
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
K010962
Syva Co., Dade Behring, Inc.
Toxicology · 27d
Cleared Nov 29, 2000
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
K002010
OraSure Technologies, Inc.
Toxicology · 149d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D
K002417
Branan Medical Corporation
Toxicology · 106d
Cleared Apr 05, 2000
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
K000466
Dade Behring, Inc.
Toxicology · 54d
Cleared Jan 20, 2000
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
K994005
Syva Co.
Chemistry · 57d
Cleared Apr 15, 1999
ACCUSIGN MTD, BIOSIGN MTD
K991080
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Feb 05, 1999
QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153
K982938
Phamatech
Toxicology · 168d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
K983703
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Sep 04, 1998
VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE
K981314
Sun Biomedical Laboratories, Inc.
Chemistry · 147d
Cleared May 26, 1998
CEDIA DAU EDDP ASSAY
K980746
Boehringer Mannheim Corp.
Toxicology · 89d
Cleared Sep 22, 1997
SYNCHRON SYSTEMS METHADONE REAGENT
K973069
Beckman Instruments, Inc.
Toxicology · 35d
Cleared Aug 04, 1997
METHADONE EIA ASSAY
K972526
Diagnostic Reagents, Inc.
Toxicology · 39d
Cleared Aug 15, 1996
ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY
K962673
Princeton BioMeditech Corp.
Toxicology · 37d
Cleared Nov 17, 1995
CEDIA DAU METHADONE ASSAY
K954227
Microgenics Corp.
Toxicology · 67d
Cleared Nov 13, 1995
AXSYM METHADONE
K953499
Abbott Laboratories
Toxicology · 110d
Cleared Dec 29, 1994
AUTO-LYTE METHADONE DIA
K944056
Solarcare Technologies Corp,Inc.
Toxicology · 132d