Product Code: DJR FDA class 2 21 CFR 862.3620

Enzyme Immunoassay, Methadone

Clinical Toxicology

The Enzyme Immunoassay for Methadone is a laboratory test using antibody-based enzyme immunoassay technology to detect and quantify methadone in biological specimens, used in clinical monitoring of patients on methadone maintenance therapy and in drug of abuse screening programs. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3620 within the Clinical Toxicology specialty. This device is eligible for third-party 510(k) review.

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Basic Information

Product Code: DJR
Device Class: FDA class 2
Regulation Number: 862.3620
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 63 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K192433	LZI Methadone II Enzyme Immunoassay	Oct 04, 2019	Substantially Equivalent	Lin-Zhi International, Inc.
K182779	ARK EDDP Assay	Nov 21, 2018	Substantially Equivalent	Ark Diagnostics, Inc.
K170416	LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators	Jun 26, 2017	Substantially Equivalent	Lin-Zhi International, Inc.
K160793	First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)	Aug 17, 2016	Substantially Equivalent	W.H.P.M., Inc.
K152025	AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)	Oct 05, 2015	Substantially Equivalent	Assure Tech. Co., Ltd.
K151395	Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets	Jul 24, 2015	Substantially Equivalent	Immunalysis Corporation
K151441	First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test	Jun 29, 2015	Substantially Equivalent	W.H.P.M., Inc.
K131232	WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)	May 31, 2013	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K092272	RANDOX METHADONE ASSAY	Nov 18, 2010	Substantially Equivalent	Randox Laboratories, Ltd.
K092258	RANDOX METABOLITE (EDDP) ASSAY	Nov 09, 2010	Substantially Equivalent	Randox Laboratories, Ltd.
K092048	ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP	Apr 19, 2010	Substantially Equivalent	Biosite Incorporated
K081378	DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS	Jan 14, 2009	Substantially Equivalent	Thermo Fisher Scientific
K062637	VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V	Nov 22, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K060791	TRIAGE TOX DRUG SCREEN, MODEL 94400	Jun 22, 2006	Substantially Equivalent	Biosite Incorporated
K052197	FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST	Jun 09, 2006	Substantially Equivalent	W.H.P.M., Inc.
K051058	METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS	Mar 29, 2006	Substantially Equivalent	Lin-Zhi International, Inc.
K040570	RANDOX METHADONE ASSAY	May 10, 2004	Substantially Equivalent	Randox Laboratories, Ltd.
K031797	METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)	Oct 10, 2003	Substantially Equivalent	Lin-Zhi International, Inc.
K023617	DRI METHADONE METABOLITE ENZYME IMMUNOASSAY	Aug 27, 2003	Substantially Equivalent	Microgenics Corp.
K023856	VISUALINE METHADONE DIPSTRIPTEST	Aug 25, 2003	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K023869	'RAPIDTEC'-5M-MULTIPLE DIP TEST	Apr 30, 2003	Substantially Equivalent	American Bio Medica Corp.
K023317	METHADONE ENZYME IMMUNOASSAY	Dec 12, 2002	Substantially Equivalent	Lin-Zhi International, Inc.
K023252	RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020	Nov 22, 2002	Substantially Equivalent	Icn Biomedicals, Inc.
K021512	COBAS INTEGRA ONLINE DAT II METHADONE II	Jul 16, 2002	Substantially Equivalent	Roche Diagnostics Corp.
K021505	ONLINE DAT II METHADONE II	Jul 16, 2002	Substantially Equivalent	Roche Diagnostics Corp.
K013001	METHADONE	Mar 20, 2002	Substantially Equivalent	Abbott Laboratories
K013796	LIVESURE METHADONE SCREEN TESTS	Nov 26, 2001	Substantially Equivalent	Pan Probe Biotech, Inc.
K012164	'RAPIDONE'-METHADONE TEST	Nov 20, 2001	Substantially Equivalent	American Bio Medica Corp.
K012595	ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE	Oct 15, 2001	Substantially Equivalent	ACON Laboratories, Inc.
K011131	METHADONE MICROPLATE EIA URINE APPLICATION	Jul 31, 2001	Substantially Equivalent	Cozart Bioscience , Ltd.
K010015	INSTANT-VIEW METHADONE URINE CASSETTE TEST	May 29, 2001	Substantially Equivalent	Alfa Scientific Designs, Inc.
K010014	INSTANT-VIEW METHADONE URINE DIP STRIP TEST	May 29, 2001	Substantially Equivalent	Alfa Scientific Designs, Inc.
K010962	EMIT II PLUS METHADONE ASSAY, MODEL OSRE229	Apr 26, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K002010	STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421	Nov 29, 2000	Substantially Equivalent	OraSure Technologies, Inc.
K002417	BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D	Nov 22, 2000	Substantially Equivalent	Branan Medical Corporation
K000466	URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A	Apr 05, 2000	Substantially Equivalent	Dade Behring, Inc.
K994005	SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL	Jan 20, 2000	Substantially Equivalent	Syva Co.
K991080	ACCUSIGN MTD, BIOSIGN MTD	Apr 15, 1999	Substantially Equivalent	Princeton BioMeditech Corp.
K982938	QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153	Feb 05, 1999	Substantially Equivalent	Phamatech
K983703	MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE	Dec 11, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K981314	VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE	Sep 04, 1998	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K980746	CEDIA DAU EDDP ASSAY	May 26, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K973069	SYNCHRON SYSTEMS METHADONE REAGENT	Sep 22, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K972526	METHADONE EIA ASSAY	Aug 04, 1997	Substantially Equivalent	Diagnostic Reagents, Inc.
K962673	ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY	Aug 15, 1996	Substantially Equivalent	Princeton BioMeditech Corp.
K954227	CEDIA DAU METHADONE ASSAY	Nov 17, 1995	Substantially Equivalent	Microgenics Corp.
K953499	AXSYM METHADONE	Nov 13, 1995	Substantially Equivalent	Abbott Laboratories
K944056	AUTO-LYTE METHADONE DIA	Dec 29, 1994	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K944074	CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST	Dec 02, 1994	Substantially Equivalent	Beckman Instruments, Inc.
K934667	METHADONE ENZYME IMMUNOASSAY	Jan 26, 1994	Substantially Equivalent	Diagnostic Reagents, Inc.
K934147	DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK	Nov 09, 1993	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K930928	ROCHE ABUSCREEN ONLINE FOR METHADONE	Sep 24, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K931780	METHADONE METABOLITE EIA ASSAY	Aug 23, 1993	Substantially Equivalent	Diagnostic Reagents, Inc.
K920858	IL TEST METHADONE	Apr 24, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K920751	SYVA EMIT II METHADONE ASSAY	Mar 13, 1992	Substantially Equivalent	Syva Co.
K911954	REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION	May 23, 1991	Substantially Equivalent	Bio-Rad
K884968	TDX METHADONE ASSAY	Dec 16, 1988	Substantially Equivalent	Abbott Laboratories
K873899	REVISED LABELING FOR SYVA METHADONE ASSAYS	Oct 28, 1987	Substantially Equivalent	Syva Co.
K873750	LABELING CHANGES COAT-A-COUNT METHADONE IN URINE	Oct 15, 1987	Substantially Equivalent	Diagnostic Products Corp.
K870937	COAT-A-COUNT METHADONE TKMD1	Mar 19, 1987	Substantially Equivalent	Diagnostic Products Corp.
K850953	EMIT 700 METHADONE ASSAY	Apr 01, 1985	Substantially Equivalent	Syva Co.
K842676	EMIT D.A.U. METHADONE ASSAY	Sep 26, 1984	Substantially Equivalent	Syva Co.
K840060	EMIT ST URINE METHADONE ASSAY	Mar 19, 1984	Substantially Equivalent	Syva Co.