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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: LCD FDA class 2

    Enzyme Immunoassay, Gentamicin

    Clinical Toxicology

    View full classification →

    Enzyme immunoassay for gentamicin is a laboratory test system used in clinical toxicology to quantify serum levels of gentamicin, an aminoglycoside antibiotic with a narrow therapeutic window requiring routine monitoring to prevent nephrotoxicity and ototoxicity. It is FDA Class 2, requiring 510(k) premarket clearance. The product code is LCD, regulated under 21 CFR 862.3450, in the Clinical Toxicology specialty. Third-party review eligibility applies.

    510(k) Clearances

    37 matches
    K Number
    Device Name
    ARCHITECT iGentamicin
    ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS
    MULTIGENT GENTAMICIN
    VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE
    ROCHE ONLINE GENTAMICIN
    RANDOX GENTAMICIN
    IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
    EMIT 2000 GENTAMICIN PLUS ASSAY
    GENTAMICIN FLEX REAGENT CARTRIDGE
    EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
    ACS GENTAMICIN
    IL TEST GENTAMICIN CALIBRATORS
    AXSYM GENTAMICIN
    QMS GENTAMICIN ASSAY
    CEDIA(R) GENTAMICIN ASSAY
    DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD
    IL GENTAMICIN ASSAY SYSTEM
    MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR
    STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.
    TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD
    EMIT CONVENIENCE PACK: GENTAMICIN ASSAY
    EMIT QST GENTAMICIN ASSAY
    EMIT GENTAMICIN ASSAY
    EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
    EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS
    TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN
    DETERMINATION OF GENTAMICIN
    ACA GENTAMICIN TEST PACK
    DU PONT GENTAMICIN ASSAY REAGENTS
    STRATUS GENTAMICIN FLUOROMETRIC ENZYM
    EMIT AMD GENTAMICIN ASSAY
    EMIT QST TOBRAMYCIN ASSAY
    EMIT QST GENTAMICIN ASSAY
    SOPHEIA GENTAMICIN EIA KIT
    GENTAMICIN REAGENT TEST KIT
    VIRGO IPA FOR DETECTION OF GENTAMICIN
    EMIT TOBRAMYCIN 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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