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510(k) Data Aggregation

    K Number
    K050053
    Device Name
    HEMORAM/AGGRAM ANALYZER
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2005-07-11

    (182 days)

    Product Code
    JPA
    Regulation Number
    864.5425
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K030055
    Why did this record match?
    Device Name :

    HEMORAM/AGGRAM ANALYZER

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

    The AggRaM Analyzer is a 4-channel aggregometer designed to perform platelet aggregation and Ristocetin cofactor testing on patients for hemostasis abnormalities. Platelet aggregation studies are performed to quantitate platelet response and identify abnormal platelet function. The agonist, Ristocetin, can be used in the diagnosis of von Willebrand's disease. "Nibeoous" reagents are used to quantitate the von Willebrand factor activity.

    Device Description

    AggRAM Analyzer

    AI/ML Overview

    The provided text is a 510(k) clearance letter for the HemoRam/AggRAM Analyzer System and its indications for use. It does not contain information about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth methodologies.

    Therefore, I cannot extract the requested information from the provided document. The document primarily focuses on the regulatory clearance of the device based on its substantial equivalence to previously marketed devices.

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