Atlas FDA

DJR

63 FDA 510(k) clearances · Product code

76 daysmedian time to decision
279 days90th percentile
63clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Methadone
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3620
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
2010: 3 · 2011: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
LZI Methadone II Enzyme Immunoassay (K192433)Lin-Zhi International, Inc.2019-10-04
ARK EDDP Assay (K182779)Ark Diagnostics, Inc.2018-11-21
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators (K170416)Lin-Zhi International, Inc.2017-06-26
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.2016-08-17
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.2015-10-05
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets (K151395)Immunalysis Corporation2015-07-24
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (K151441)W.H.P.M., Inc.2015-06-29
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) (K131232)Guangzhou Wondfo Biotech Co., Ltd.2013-05-31
RANDOX METHADONE ASSAY (K092272)Randox Laboratories, Ltd.2010-11-18
RANDOX METABOLITE (EDDP) ASSAY (K092258)Randox Laboratories, Ltd.2010-11-09
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP (K092048)Biosite Incorporated2010-04-19
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS (K081378)Thermo Fisher Scientific2009-01-14
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V (K062637)Ortho-Clinical Diagnostics, Inc.2006-11-22
TRIAGE TOX DRUG SCREEN, MODEL 94400 (K060791)Biosite Incorporated2006-06-22
FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST (K052197)W.H.P.M., Inc.2006-06-09
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS (K051058)Lin-Zhi International, Inc.2006-03-29
RANDOX METHADONE ASSAY (K040570)Randox Laboratories, Ltd.2004-05-10
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) (K031797)Lin-Zhi International, Inc.2003-10-10
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY (K023617)Microgenics Corp.2003-08-27
VISUALINE METHADONE DIPSTRIPTEST (K023856)Sun Biomedical Laboratories, Inc.2003-08-25
'RAPIDTEC'-5M-MULTIPLE DIP TEST (K023869)American Bio Medica Corp.2003-04-30
METHADONE ENZYME IMMUNOASSAY (K023317)Lin-Zhi International, Inc.2002-12-12
RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 (K023252)Icn Biomedicals, Inc.2002-11-22
ONLINE DAT II METHADONE II (K021505)Roche Diagnostics Corp.2002-07-16
COBAS INTEGRA ONLINE DAT II METHADONE II (K021512)Roche Diagnostics Corp.2002-07-16
METHADONE (K013001)Abbott Laboratories2002-03-20
LIVESURE METHADONE SCREEN TESTS (K013796)Pan Probe Biotech, Inc.2001-11-26
'RAPIDONE'-METHADONE TEST (K012164)American Bio Medica Corp.2001-11-20
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE (K012595)ACON Laboratories, Inc.2001-10-15
METHADONE MICROPLATE EIA URINE APPLICATION (K011131)Cozart Bioscience , Ltd.2001-07-31
INSTANT-VIEW METHADONE URINE DIP STRIP TEST (K010014)Alfa Scientific Designs, Inc.2001-05-29
INSTANT-VIEW METHADONE URINE CASSETTE TEST (K010015)Alfa Scientific Designs, Inc.2001-05-29
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 (K010962)Syva Co., Dade Behring, Inc.2001-04-26
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 (K002010)OraSure Technologies, Inc.2000-11-29
BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D (K002417)Branan Medical Corporation2000-11-22
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A (K000466)Dade Behring, Inc.2000-04-05
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL (K994005)Syva Co.2000-01-20
ACCUSIGN MTD, BIOSIGN MTD (K991080)Princeton BioMeditech Corp.1999-04-15
QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153 (K982938)Phamatech1999-02-05
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE (K983703)Roche Diagnostic Systems, Inc.1998-12-11
VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE (K981314)Sun Biomedical Laboratories, Inc.1998-09-04
CEDIA DAU EDDP ASSAY (K980746)Boehringer Mannheim Corp.1998-05-26
SYNCHRON SYSTEMS METHADONE REAGENT (K973069)Beckman Instruments, Inc.1997-09-22
METHADONE EIA ASSAY (K972526)Diagnostic Reagents, Inc.1997-08-04
ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY (K962673)Princeton BioMeditech Corp.1996-08-15
CEDIA DAU METHADONE ASSAY (K954227)Microgenics Corp.1995-11-17
AXSYM METHADONE (K953499)Abbott Laboratories1995-11-13
AUTO-LYTE METHADONE DIA (K944056)Solarcare Technologies Corp,Inc.1994-12-29
CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST (K944074)Beckman Instruments, Inc.1994-12-02
METHADONE ENZYME IMMUNOASSAY (K934667)Diagnostic Reagents, Inc.1994-01-26
DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK (K934147)E.I. Dupont DE Nemours & Co., Inc.1993-11-09
ROCHE ABUSCREEN ONLINE FOR METHADONE (K930928)Roche Diagnostic Systems, Inc.1993-09-24
METHADONE METABOLITE EIA ASSAY (K931780)Diagnostic Reagents, Inc.1993-08-23
IL TEST METHADONE (K920858)Instrumentation Laboratory CO1992-04-24
SYVA EMIT II METHADONE ASSAY (K920751)Syva Co.1992-03-13
REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION (K911954)Bio-Rad1991-05-23
TDX METHADONE ASSAY (K884968)Abbott Laboratories1988-12-16
REVISED LABELING FOR SYVA METHADONE ASSAYS (K873899)Syva Co.1987-10-28
LABELING CHANGES COAT-A-COUNT METHADONE IN URINE (K873750)Diagnostic Products Corp.1987-10-15
COAT-A-COUNT METHADONE TKMD1 (K870937)Diagnostic Products Corp.1987-03-19
EMIT 700 METHADONE ASSAY (K850953)Syva Co.1985-04-01
EMIT D.A.U. METHADONE ASSAY (K842676)Syva Co.1984-09-26
EMIT ST URINE METHADONE ASSAY (K840060)Syva Co.1984-03-19

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