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510(k) Data Aggregation

    K Number
    K982150
    Device Name
    EL-ANA PROFILES: EL-ENA/4
    Manufacturer
    THERATEST LABORATORIES, INC.
    Date Cleared
    1998-08-13

    (56 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

    The TheraTest EL-ANA Profiles: EL-ENA/4 is an in vitro diagnostic test for the screening of autoantibodies in human serum directed against the following extractable nuclear antigens: Sm, nRNP, SSA and SSB. This screening aids in the diagnosis of systemic lupus erythematosus and related autoimmune disorders.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the TheraTest EL-ANA Profiles: EL-ENA/4 device. It declares the device substantially equivalent to legally marketed predicate devices. Unfortunately, the document does not contain the specific details about the acceptance criteria and the study that proves the device meets those criteria.

    This letter is a regulatory approval, not a scientific publication detailing the performance study. To find the information requested, one would typically need to consult the original 510(k) submission document or related technical reports, which are not provided here.

    Therefore, I cannot fulfill your request for the table of acceptance criteria and the detailed study information based on the provided text.

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