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510(k) Data Aggregation

    K Number
    K023761
    Device Name
    PLATELETWORKS, MODELS PW-A, PW-C
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2003-02-14

    (98 days)

    Product Code
    JOZ
    Regulation Number
    864.5700
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K990398
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K990398

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Plateletworks (K990398) is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood samples taken during cardiac interventional procedures as measured by a change in platelet count due to activation of functional platelets. It may be used at the point-of-care on the Ichor or Coulter hematology analyzers as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.

    Device Description

    Automated Platelet Aggregation System

    AI/ML Overview

    I am sorry, but there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) clearance letter from the FDA for the Plateletworks® device, indicating substantial equivalence to a predicate device and outlining regulatory information. It does not contain details about specific performance studies or acceptance criteria.

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