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510(k) Data Aggregation

    K Number
    K960987
    Device Name
    LIQUICHEK RHEUMATOID FACTOR CONTROL
    Manufacturer
    BIO-RAD
    Date Cleared
    1996-06-04

    (85 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K923578
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Liquichek Rheumatoid Factor Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory's rheumatoid factor testing methodologies.

    Device Description

    Liquichek Rheumatoid Factor Control is prepared from human serum with added constituents of human origin.

    AI/ML Overview

    This is a 510(k) summary for a medical device called "Liquichek Rheumatoid Factor Control" and concerns a quality control serum, not an AI/ML powered device. As such, the information requested in your prompt (acceptance criteria, study details like sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission for a quality control product.

    The document discusses the intended use, device description, and a comparison of technological characteristics to a previously cleared device for establishing substantial equivalence. It does not contain any performance data against acceptance criteria in the way you've described for an AI/ML diagnostic or prognostic device.

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