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510(k) Data Aggregation

    K Number
    K021103
    Device Name
    MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    2002-04-24

    (19 days)

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

    The Zeus Scientific, Inc. AtheNA Multi-Lyte™ ANA Test System is intended for the semiquantitative detection of IgG class antibody to 8 separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, Histone) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum and the qualitative detection of IgG class antibody to ANA in human serum. The test system is intended to be used as an aid in the diagnosis of this in namautoimmune disorders. This test is for in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the Zeus Scientific, Inc. AtheNA Multi-Lyte™ ANA Test System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain the detailed acceptance criteria for device performance, nor does it describe a study that directly proves the device meets those criteria. The letter is an approval based on the submission, not the submission itself.

    Therefore, I cannot provide the requested information from this document. To fulfill your request, I would need access to the actual 510(k) submission (K021103) which typically includes summaries of performance studies and their acceptance criteria.

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