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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: MST FDA class 2

    Antibodies, Gliadin

    Immunology

    View full classification →

    An Antibodies to Gliadin test system is an immunological in vitro diagnostic device used to detect antigliadin antibodies in serum, which are markers associated with celiac disease and gluten sensitivity, aiding in diagnosis and monitoring. It is classified as FDA Class 2, requiring 510(k) clearance, with product code MST under 21 CFR 866.5750 in the Immunology specialty. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    42 matches
    K Number
    Device Name
    ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
    AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
    GLIADIN IGA AND GLIADIN LGA
    QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
    QUANTA FLASH (TM) DGP SCREEN
    ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
    IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
    EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
    EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
    BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
    ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
    QUANTA LITE H-TTG/DGP SCREEN
    QUANTA LITE CELIAC DGP SCREEN
    FIDIS CELIAC
    IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02
    AESKULISA GLIA A AND AESKULISA GLIA G
    QUANTA LITE GLIADIN IGG II
    QUANTA LITE GLIADIN IGA II
    FIDIS CELIAC
    VARELISA GLIADIN IGG ANTIBODIES
    VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
    DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
    DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
    MDI GLIADIN G TEST
    GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM
    GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
    MDI GLIADIN A TEST
    THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
    AUTOSTAT II ANTI-GLIADIN IGG ELISA
    AUTOSTAT II ANTI-GLIADIN IGA ELISA
    THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
    GLIADIN IGG ELISA TEST SYSTEM
    GLIADIN IGA ELISA TEST SYSTEM
    GLIADIN ANTIBODIES ELISA
    UNICAP GLIADIN IGA ASSAY
    UNICAP GLIADIN IGG ASSAY
    BINDAZYME ANTIGLIADIN IGG
    BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT
    QUANTA LITE IGA GLIADIN ELISA
    IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT
    QUANTA LITE IGG GLIADIN ELISA
    IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT

    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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