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510(k) Data Aggregation

    K Number
    K083381
    Device Name
    EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2009-04-15

    (152 days)

    Product Code
    LRM
    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

    The EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) test kit is designed for the quantitative or qualitative determination of IgG class autoantibodies against double-stranded genomic DNA (dsDNA) in human serum and EDTA or citrate plasma. It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding the 510(k) premarket notification for the EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) device. While it states that the device is substantially equivalent to a predicate device and can be marketed, it does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance study details.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample size, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided text.

    The document primarily focuses on regulatory approval and classification, not on the technical details of the validation study.

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