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    K Number
    K061842
    Device Name
    QUANTA LITE PBC SCREEN IGG/IGA ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2006-10-18

    (111 days)

    Product Code
    NRI,DBM,NUM
    Regulation Number
    866.5090
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUANTA LITE PBC SCREEN IGG/IGA ELISA

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

    The QUANTA Lite™ PBC Screen IgG/IgA ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies, gp210 antibodies, and sp100 antibodies of the IgG and/or IgA class in human serum. The presence of mitochondrial, gp210, and sp100 antibodies of the IgG and/or IgA class can be used in conjunction with other clinical and laboratory findings to aid in the diagnosis of primary biliary cirrhosis.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but after carefully reviewing the provided document, I was unable to find the information necessary to answer your request regarding the acceptance criteria, study details, and specific performance metrics of the QUANTA Lite™ PBC Screen IgG/IgA ELISA device. The document is an FDA 510(k) clearance letter and an Indications for Use statement, which primarily confirm the device's substantial equivalence to a predicate device and its intended use. It does not contain the detailed study results or acceptance criteria you are looking for.

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