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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: GGC FDA class 2

    Control, Plasma, Abnormal

    Hematology

    View full classification →

    Control, Plasma, Abnormal (product code GGC) is a quality control material containing plasma with abnormal coagulation characteristics, used to verify the accuracy and precision of coagulation assays in clinical hematology laboratories. This device is classified as FDA Class 2, indicating moderate risk, and does not require premarket notification under the current classification. Regulated under 21 CFR 864.5425 in the Hematology specialty (HE), this device carries no flags for implantation, life support, GMP exemption, or third-party review.

    510(k) Clearances

    40 matches
    K Number
    Device Name
    HEMOSIL LA POSITIVE CONTROL
    SPECIALTY ASSAYED CONTROL-2
    PLASMACON N, PLASMACON L-1, PLASMACON L-2
    STA - CONTROL LA 1+2
    CRYOCHECK WEAK LUPUS POSITIVE CONTROL
    CONTROL PLASMA P
    LYPHOCHEK HEMOSTASIS, MODELS 798, 799
    SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
    K-ASSAY D-DIMER CONTROLS
    SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
    GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
    COAGULATION CONTROL LEVEL 3 (ABNORMAL)
    COAGULATION CONTROL LEVEL 2 (ABNORMAL)
    LA POSITIVE CONTROL PLASMA
    AT-III CONTROL PLASMA KIT
    CRYO CHECK LUPUS PLASMA
    CRYO CHECK ABNORMAL REFERENCE CHECK I & II
    POSITIVE LUPUS ANTICOAGULANT PLASMA
    STA-COAG CONTROL [P] PLUS KIT
    SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
    BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL
    PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
    CONTROL PLASMA U
    FACTOR CONTROL [P]
    COAG-CONTROL
    CONTROL PLASMA P
    AVK CONTROL I & II
    DADE(R) PROTEIN C ABNORMAL CONTRAL
    COAGULATION REFERENCE PLASMA, ABNORMAL
    ORTHO ABNORMAL PROTEIN C CONTROL PLASMA
    HEPARIN CONTROL PLASMA, FOR USE IN APTT
    ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)
    ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)
    ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III
    ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III
    ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II
    ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II
    CLP ABNORMAL COAGULATION CONTROL
    HERPES 1 AND 2 MICROASSAYS
    HPC TM (HEPARINIZED PLASMA CONTROL)

    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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