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    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: JOZ FDA class 2

    System, Automated Platelet Aggregation

    Hematology

    View full classification →

    The System, Automated Platelet Aggregation is a hematology diagnostic device used to automatically measure the aggregation response of platelets in platelet-rich plasma when exposed to various aggregating agents, providing information on platelet function for the diagnosis and monitoring of platelet disorders and management of antiplatelet therapies. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification prior to marketing. It carries product code JOZ and is regulated under 21 CFR 864.5700, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    38 matches
    K Number
    Device Name
    T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01
    AggreGuide A-100 ADP
    AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
    Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel
    ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
    CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY
    AGGREGUIDE
    MULTIPLATE 5.0 AGGREGOMETER
    DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
    CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
    VERIFYNOW-P2Y12 ASSAY
    VERIFYNOW-ASPIRIN ASSAY
    THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
    CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
    PLATELETWORKS, MODELS PW-A, PW-C
    ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
    MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)
    ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
    PLATELETWORKS
    DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
    ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM
    PLATELETWORKS
    DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/
    CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
    CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT
    AGGRO/LINK VW COFACTOR SOFTWARE
    BLOOD PLATELET ASSAY METHOD & APPARATUS
    MONITOR IV PLUS
    HELENA RISTOCETIN
    PLATELET AGGREGATION REAGENTS
    ELVI 840 AGGREGOMETER
    BETA/PAK
    COLLAGENREAGENT HORM
    REAGENT, FIREFLY #395
    SOLUBLE COLLAGEN
    PLATELET AGGREGATING REAGENTS
    THROMBO-CETIN (RISTOCETIN)
    AGGRECETIN

    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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