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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: GJT FDA class 2

    Plasma, Coagulation Factor Deficient

    Hematology

    View full classification →

    Plasma, Coagulation Factor Deficient (product code GJT) is a hematology reference plasma that lacks one or more specific coagulation factors, used as a substrate in factor assays to detect and quantify factor deficiencies in patients with bleeding disorders. 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
    CRYOcheck Factor VIII Deficient Plasma with VWF
    HemosIL Factor XII Deficient Plasma
    NOFACT IX
    NOFACT VIII
    HEMOSIL FACTOR VIII DEFICIENT PLASMA
    HEMOSIL FACTOR II DEFICIENT PLASMA
    HEMOSIL FACTOR XII DEFICIENT PLASMA
    DIAPHARMA FACTOR X KIT
    HEMOSIL FACTOR VIII DEFICIENT PLASMA
    HEMOSIL FACTOR IX DEFICIENT PLASMA
    HEMOSIL FACTOR X DEFICIENT PLASMA
    HEMOSIL FACTOR XI DEFICIENT PLASMA
    HEMOSIL FACTOR VII DEFICIENT PLASMA
    HEMOSIL FACTOR V DEFICIENT PLASMA
    CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
    CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
    PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
    CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
    CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
    COAGULATION FACTOR V DEFICIENT PLASMA
    PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)
    CRYO CHECK FACTOR V DEFICIENT PLASMA
    CRYO CHECK FACTOR IX DEFICIENT PLASMA
    CRYO CHECK FACTOR X DEFICIENT PLASMA
    CRYO CHECK FACTOR VII DEFICIENT PLASMA
    CRYO CHECK FACTOR VIII DEFICIENT PLASMA
    FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
    UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
    UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
    STA - LIATEST VWF TEST KIT
    STA-VWF CALIBRATOR KIT
    PROTEIN C DEFICIENT PLASMA
    HEMOLAB COFAC IX
    BIOMERIEUX HEMOLAB COFAC II
    BIOMERIEUX HEMOLAB COFAC VII
    BIOMERIEUX HEMOLAB COFAC X
    FACTOR VIII DEFICIENT PLASMA
    FACTOR VII DEFICIENT PLASMA
    FACTOR X DEFICIENT PLASMA
    FACTOR
    STAGO FACTOR II-DEFICIENT PLASMA
    STAGO FACTOR V-DEFICIENT PLASMA
    STAGO FACTOR IX-DEFICIENT PLASMA
    STAGO FACTOR VII-DEFICIENT PLASMA
    STAGO FACTOR XI-DEFICIENT PLASMA
    STAGO FACTOR X-DEFICIENT PLASMA
    STAGO FACTOR XII-DEFICIENT PLASMA
    BIOMERIEUX HEMOLAB COFAC VIII
    CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA
    CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA

    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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