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 Abbott Laboratories.

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 Aug 17, 2016
First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
K160793
W.H.P.M., Inc.
Toxicology · 147d
Cleared Oct 05, 2015
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
K152025
Assure Tech. Co., Ltd.
Chemistry · 75d
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 Jun 29, 2015
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
K151441
W.H.P.M., Inc.
Chemistry · 31d
Cleared May 31, 2013
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
K131232
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 30d
Cleared Nov 18, 2010
RANDOX METHADONE ASSAY
K092272
Randox Laboratories, Ltd.
Toxicology · 478d
Cleared Nov 09, 2010
RANDOX METABOLITE (EDDP) ASSAY
K092258
Randox Laboratories, Ltd.
Toxicology · 469d
Cleared Apr 19, 2010
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
K092048
Biosite Incorporated
Chemistry · 286d
Cleared Jan 14, 2009
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
K081378
Thermo Fisher Scientific
Toxicology · 243d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V
K062637
Ortho-Clinical Diagnostics, Inc.
Chemistry · 78d
Cleared Jun 22, 2006
TRIAGE TOX DRUG SCREEN, MODEL 94400
K060791
Biosite Incorporated
Toxicology · 91d
Cleared Jun 09, 2006
FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST
K052197
W.H.P.M., Inc.
Toxicology · 301d
Cleared Mar 29, 2006
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
K051058
Lin-Zhi International, Inc.
Toxicology · 337d
Cleared May 10, 2004
RANDOX METHADONE ASSAY
K040570
Randox Laboratories, Ltd.
Toxicology · 67d
Cleared Oct 10, 2003
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)
K031797
Lin-Zhi International, Inc.
Toxicology · 122d
Cleared Aug 27, 2003
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
K023617
Microgenics Corp.
Toxicology · 302d
Cleared Aug 25, 2003
VISUALINE METHADONE DIPSTRIPTEST
K023856
Sun Biomedical Laboratories, Inc.
Chemistry · 279d
Cleared Apr 30, 2003
'RAPIDTEC'-5M-MULTIPLE DIP TEST
K023869
American Bio Medica Corp.
Toxicology · 161d
Cleared Dec 12, 2002
METHADONE ENZYME IMMUNOASSAY
K023317
Lin-Zhi International, Inc.
Toxicology · 70d
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

About Product Code DJR - Regulatory Context