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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: GGN FDA class 2

    Plasma, Coagulation Control

    Hematology

    View full classification →

    Plasma, Coagulation Control (product code GGN) is a quality control plasma preparation used to assess the performance of coagulation testing systems and ensure the accuracy of clotting 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

    50+ matches
    K Number
    Device Name
    VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
    VALIDATE Heparin Calibration Verification/Linearity Test Kit
    George King Coumadin Plasma
    VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
    VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
    VisuCon-F Low Fibrinogen Control Plasma
    POOL NORM
    HEMOSIL D-DIMER HS 500 CONTROL
    DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
    I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
    STA- COAG CONTROL (N+ABN) PLUS
    HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
    VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
    AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
    PT-MULTI-CALIBRATOR, MODEL OPAT07
    CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
    HEPARIN ASSAY CONTROLS
    VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA
    HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
    HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
    I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02
    TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
    COAGUCHEK XS PT CONTROLS
    HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
    BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
    TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS
    BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
    PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
    CONTROL PLASMA N, PROC CONTROL PLASMA
    CONTROL PLASMA N AND CONTROL PLASMA P
    PURPLE/BLACK HEPARIN ASSAY CONTROL
    HEPARINASE HR ACT CONTROL, MODEL 550-12
    LYPHOCHEK HEMOSTASIS CONTROL
    LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
    LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
    CONTROL PLASMA LMW HEPARIN
    LIQUICHEK D-DIMER CONTROL, MODEL 356, 357
    VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL
    HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
    HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)
    HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)
    LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
    PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
    STA -CALIBRATOR HBPM/LMWH KIT
    STA-QUALITY HBPM/LMWH KIT
    THROMBOSTRATE CONTROL PLASMAS
    HMP CONTROLS (TAS) RAPIDPOINT
    POLLER CALIBRANTS
    CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
    HEPARIN CONTROL PLASMA LEVEL 2

    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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