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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: GGP FDA class 2

    Test, Qualitative And Quantitative Factor Deficiency

    Hematology

    View full classification →

    The Test, Qualitative and Quantitative Factor Deficiency (product code GGP) is a hematology assay system used to detect and measure deficiencies in specific coagulation factors, supporting the diagnosis of inherited or acquired bleeding disorders such as hemophilia. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7290 in the Hematology specialty (HE), it is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HemosIL Chromogenic Factor IX
    vWF Ag
    CRYOcheck Chromogenic Factor IX
    HemosIL von Willebrand Factor Antigen
    HemosIL von Willebrand Factor Antigen
    Cryocheck Chromogenic Factor VIII
    CRYOcheck FVIII Inhibitor Kit
    INNOVANCE Free PS Ag
    HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
    HEMOSIL PROTEIN S ACTIVITY ASSAY
    STA LIATEST FREE PS
    THROMBO TEK PSE, MODEL 90-480
    FACTOR VIII ANTIBODY SCREEN
    SPECTROLYSE PAI-1, MODEL 101201
    HEMOSIL PROCLOT
    TRIAGE PROTEIN C TEST
    HEMOSIL PROTEIN C
    VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
    HEMOSIL PROS
    BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
    CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5
    VISULIZE FACTOR IX ANTIGEN KIT
    CRYOCHECK CLOT S
    COATEST SP FVIII
    CRYOCHECK CLOT C
    HEMOSIL VON WILLEBRAND ACTIVITY
    REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
    MODIFICATION TO COATEST FACTOR VIII
    CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50
    PROTEIN S AC
    IMUBIND TPA ELISA, MODEL 860
    IMUBIND PLASMA PAI-1 ELISA,MODEL 822
    ACTICLOT PROTEIN S, MODEL 843L
    IL TEST PROS
    STA-LIATEST FREE PROTEIN S TEST KIT
    IL TEST FREE PROTEIN S
    COALIZA PROTEIN S-FREE
    REFACTO LABORATORY STANDARD
    PROTEIN C REAGENT
    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
    SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
    GTI-FVIII INHIBITOR ASSAY
    IL TEST VON WILLEBRAND FACTOR
    BIOCLOT APC SENSITIVITY
    REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT
    VFE
    COAMATIC PLASMIN INHIBITOR
    IL TEST PLASMIN INHIBITOR
    SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY
    IL TEST PLASMINOGEN

    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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