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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: DKZ FDA class 2

    Enzyme Immunoassay, Amphetamine

    Clinical Toxicology

    View full classification →

    The Enzyme Immunoassay for Amphetamine is a clinical laboratory test system that uses enzyme-linked immunological techniques to detect and quantify amphetamine in patient specimens, primarily for toxicological screening. It is a Class 2 device requiring a 510(k) premarket notification to demonstrate substantial equivalence before marketing. The product code is DKZ, regulated under 21 CFR 862.3100, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    DRI Ecstasy Plus Assay
    AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
    Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
    Quidel Triage® TOX Drug Screen, 94600
    Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
    Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro
    Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)
    BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
    QuickScreen Pro Multi Drug Screening Test, Model 9395Z
    INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
    CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
    Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
    UCP COMPACT DRUG TESTS
    ACCU NEWS Drug Screening Test Card/Urine Cup
    AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)
    Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)
    UCP Drug Test Mini Cups
    Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)
    RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
    Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
    Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
    Chemtrue Multi-Panel DOA DIP Card Tests
    CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
    QUICKSCREEN AMPHETINE 500 TEST
    UCP MULTI-DRUG TEST KEY CUPS
    WONDFO MULTI-DRUG URINE TEST CUP, PANEL
    LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
    ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD
    GENPRIME DRUGS OF ABUSE READER SYSTEM
    INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
    UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
    Advin Multi-Drug Screen Test Cassette, Dip Card and Cup
    POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
    UCP HOME DRUG SCREENING TEST; CARDS, CUPS
    PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
    UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
    WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
    UCP HOME DRUG SCREENING TEST CUPS
    WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;
    WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST
    CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS
    AMEDITECH IMMUTEST MILTI-DRUG SCREEN
    WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST
    ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
    THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
    RANDOX ECSTASY (MDMA) ASSAY
    CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS
    LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS
    AMPHETAMINES II ASSAY
    THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY

    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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