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510(k) Data Aggregation

    K Number
    K021648
    Device Name
    QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2002-09-20

    (123 days)

    Product Code
    NJF
    Regulation Number
    866.5120
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    NJF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The QUANTA Lite™ Actin ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum. Detection of these antibodies is an aid in diagnosis of certain autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).

    Device Description

    The QUANTA Lite™ Actin ELISA kit is an enzyme-linked immunosorbent assay (ELISA).

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the "QUANTA Lite™ Actin ELISA" device, confirming its substantial equivalence to a legally marketed predicate device.

    While it mentions the device and its indications for use, it does not include:

    1. A table of acceptance criteria or reported device performance.
    2. Details about sample sizes, data provenance (test or training set).
    3. Information on experts, ground truth establishment, or adjudication methods.
    4. Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.

    The letter is a regulatory approval document, not a detailed study report.

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