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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: DIO FDA class 2

    Enzyme Immunoassay, Cocaine And Cocaine Metabolites

    Clinical Toxicology

    View full classification →

    The Enzyme Immunoassay for Cocaine and Cocaine Metabolites is a laboratory test that uses antibody-based enzyme immunoassay technology to screen for the presence of cocaine and its metabolites in biological specimens, commonly used in drug testing and toxicology screening programs. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3250 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
    DRI Cocaine Metabolite Assay
    Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
    DRI Cocaine Metabolite Assay
    Emit II Plus Cocaine Metabolite Assay
    Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
    MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
    Quest Diagnostics HairCheck-DT (Cocaine)
    Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
    SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
    RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET
    Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set
    First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
    HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
    OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
    WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
    WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
    RANDOX COCAINE METABOLITE
    ORATECT ORAL FLUID DRUG SCREEN DEVICES
    QUICKSCREEN COCAINE 150 SCREENING TEST
    OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
    AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
    LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
    WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
    THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
    ROCHE ORAL FLUID COCAINE
    RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
    QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA
    VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
    RAPIDONE-COCAINE-150 TEST
    ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000
    ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS
    IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
    IMMUNALYSIS COCAINE ELISA FOR HAIR
    ONTRAK TESTCARD 9
    CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)
    LABONE COCAINE METABOLITE MICRO-PLATE EIA
    ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE
    URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
    RANDOX EVIDENCE
    AML HAIRCHECK-DT (COCAINE)
    TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
    EMIT II PLUS COCAINE METABOLITE ASSAY
    COZART EIA COCAINE ORAL FLIUD KIT
    QUICKTOX MULTIPLE DRUG DIPCARD
    ONLINE DAT II COCAINE II
    COBAS INTEGRA ONLINE DAT II COCAINE II
    AMEDICA DRUG SCREEN COCAINE TEST
    QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
    LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC

    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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