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510(k) Data Aggregation

    K Number
    K031450
    Device Name
    QUANTA PLEX ENA PROFILE 6
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2003-06-25

    (49 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 QUANTA Plex™ ENA Profile 6 is a fluorescent immunosorbent assay for the semi-quantitative detection of Sm, RNP, SSA, SSB, Scl-70 and Jo-1 autoantibodies in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus and related connective tissue diseases such as Sjögren's syndrome, scleroderma and polymyositis.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for an in vitro diagnostic device, the QUANTA Plex™ ENA Profile 6. The provided text is a letter from the FDA determining substantial equivalence to a predicate device, along with the "Indications For Use" statement.

    The document does not contain the acceptance criteria, study details, or performance data for the QUANTA Plex™ ENA Profile 6 being reviewed. It only confirms the FDA's decision based on the information submitted by the manufacturer.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications from this document. This kind of detailed information is typically found in the full 510(k) submission, specifically in sections describing device performance studies and validation.

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