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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: LAF FDA class 2

    Gas Chromatography, Methamphetamine

    Clinical Toxicology

    View full classification →

    Gas chromatography for methamphetamine detection is an analytical method used in clinical toxicology laboratories to identify and measure methamphetamine concentrations in patient specimens. It is classified as FDA Class 2, indicating moderate risk with a requirement for 510(k) premarket clearance. The product code is LAF, regulated under 21 CFR 862.3610, in the Clinical Toxicology specialty. Third-party review eligibility applies.

    510(k) Clearances

    49 matches
    K Number
    Device Name
    SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
    Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
    Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
    Rapid Tox Cup II
    Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
    Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls
    Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
    First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
    RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
    LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
    PSYCHEMEDICS METHAMPHETAMINE EIA
    LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS
    WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST
    OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)
    THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
    ROCHE FLUDI METHAMPHETAMINE
    RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050
    QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
    METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS
    IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS
    ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
    LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA
    AMEDICA DRUG SCREEN METHAPHETAMINE TEST
    ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
    AMPHETAMINE/METHAMPHETAMINE
    AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE
    ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
    LIVESURE METHAMPHETAMINE SCREEN TESTS
    MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)
    CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
    MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)
    AT WORK DRUG TEST, MODEL 9147T AWT
    ESCREEN SYSTEM
    FIRST CHECK HOME DRUG TEST PANEL 4
    ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
    SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST
    REDI-SCREEN
    STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
    QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
    SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
    IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
    AT HOME DRUG TEST, MODEL 9068
    REDI-TEST METHAMPHETAMINE
    DBEST METHAMPHETAMINES TEST KIT
    QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)
    ACCUSIGN MET/BIOSIGN MET
    TENONE(TM) METHAMPHETAMINE
    CEDIA(TM) PHENOBARBITAL ASSAY
    COAT-A-COUNT METHAMPHETAMIN #TKMA1

    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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