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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: DJR FDA class 2

    Enzyme Immunoassay, Methadone

    Clinical Toxicology

    View full classification →

    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.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    LZI Methadone II Enzyme Immunoassay
    ARK EDDP Assay
    LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
    First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
    AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
    Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
    First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
    WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
    RANDOX METHADONE ASSAY
    RANDOX METABOLITE (EDDP) ASSAY
    ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
    DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
    VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V
    TRIAGE TOX DRUG SCREEN, MODEL 94400
    FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST
    METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
    RANDOX METHADONE ASSAY
    METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)
    DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
    VISUALINE METHADONE DIPSTRIPTEST
    'RAPIDTEC'-5M-MULTIPLE DIP TEST
    METHADONE ENZYME IMMUNOASSAY
    RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020
    COBAS INTEGRA ONLINE DAT II METHADONE II
    ONLINE DAT II METHADONE II
    METHADONE
    LIVESURE METHADONE SCREEN TESTS
    'RAPIDONE'-METHADONE TEST
    ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
    METHADONE MICROPLATE EIA URINE APPLICATION
    INSTANT-VIEW METHADONE URINE DIP STRIP TEST
    INSTANT-VIEW METHADONE URINE CASSETTE TEST
    EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
    STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
    BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D
    URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
    SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
    ACCUSIGN MTD, BIOSIGN MTD
    QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153
    MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
    VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE
    CEDIA DAU EDDP ASSAY
    SYNCHRON SYSTEMS METHADONE REAGENT
    METHADONE EIA ASSAY
    ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY
    CEDIA DAU METHADONE ASSAY
    AXSYM METHADONE
    AUTO-LYTE METHADONE DIA
    CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST
    METHADONE ENZYME IMMUNOASSAY

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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