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510(k) Data Aggregation

    K Number
    K964963
    Device Name
    LYPHOCHEK COAGULATION CONTROL
    Manufacturer
    BIO-RAD
    Date Cleared
    1997-02-20

    (71 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K820450
    Why did this record match?
    Reference Devices :

    K820450

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

    Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.

    Device Description

    Lyphochek Coagulation Control is prepared from human plasma with added constituents of non-human origin and purified biochemicals. The control is provided in lyophilized form for increased stability.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called "Lyphochek Coagulation Control." This document describes a quality control product used to monitor the precision of coagulation systems, not a diagnostic or AI-powered device.

    Therefore, the information requested in your prompt (such as acceptance criteria, details of a study on device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable to this type of document or device.

    The document focuses on demonstrating substantial equivalence to a predicate device based on intended use, form, matrix, storage, open vial stability, and assay claims, which are typical for a quality control product submission.

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