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., Abbott Laboratories and Roche Diagnostics Corp..

63
Total
63
Cleared
114d
Avg days
1984
Since

FDA 510(k) Cleared Enzyme Immunoassay, Methadone Devices (Product Code DJR)

63 devices
1–24 of 63
Cleared Oct 04, 2019
LZI Methadone II Enzyme Immunoassay
K192433
Lin-Zhi International, Inc.
Toxicology · 29d
Cleared Nov 21, 2018
ARK EDDP Assay
K182779
ARK Diagnostics, Inc.
Toxicology · 51d
Cleared Jun 26, 2017
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
K170416
Lin-Zhi International, Inc.
Toxicology · 136d
Cleared Jul 24, 2015
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
K151395
Immunalysis Corporation
Toxicology · 59d
Cleared Jul 16, 2002
ONLINE DAT II METHADONE II
K021505
Roche Diagnostics Corp.
Toxicology · 68d
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 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 Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
K983703
Roche Diagnostic Systems, Inc.
Toxicology · 51d
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 Nov 13, 1995
AXSYM METHADONE
K953499
Abbott Laboratories
Toxicology · 110d
Cleared Dec 02, 1994
CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST
K944074
Beckman Instruments, Inc.
Toxicology · 150d
Cleared Nov 09, 1993
DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK
K934147
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 76d
Cleared Sep 24, 1993
ROCHE ABUSCREEN ONLINE FOR METHADONE
K930928
Roche Diagnostic Systems, Inc.
Toxicology · 213d
Cleared Apr 24, 1992
IL TEST METHADONE
K920858
Instrumentation Laboratory CO
Toxicology · 59d
Cleared Mar 13, 1992
SYVA EMIT II METHADONE ASSAY
K920751
Syva Co.
Toxicology · 23d
Cleared May 23, 1991
REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION
K911954
Bio-Rad
Toxicology · 22d
Cleared Dec 16, 1988
TDX METHADONE ASSAY
K884968
Abbott Laboratories
Toxicology · 16d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA METHADONE ASSAYS
K873899
Syva Co.
Toxicology · 34d
Cleared Oct 15, 1987
LABELING CHANGES COAT-A-COUNT METHADONE IN URINE
K873750
Diagnostic Products Corp.
Toxicology · 41d
Cleared Mar 19, 1987
COAT-A-COUNT METHADONE TKMD1
K870937
Diagnostic Products Corp.
Toxicology · 10d
Cleared Apr 01, 1985
EMIT 700 METHADONE ASSAY
K850953
Syva Co.
Toxicology · 25d

About Product Code DJR - Regulatory Context