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510(k) Data Aggregation

    K Number
    K113143
    Device Name
    IMMULISA SCI-70 ANTIBODY ELISA
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2011-12-02

    (38 days)

    Product Code
    LLL
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of ScI-70 antibodies in human serum as an aid in diagnosis of systemic sclerosis / scleroderma in conjunction with other laboratory and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the ImmuLisa Scl-70 Antibody ELISA, which indicates the device has been reviewed and found substantially equivalent to legally marketed predicate devices. However, it does not include details about acceptance criteria, specific study results, sample sizes, expert qualifications, or ground truth establishment for performance studies.

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