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510(k) Data Aggregation

    K Number
    K030741
    Device Name
    AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA
    Manufacturer
    HYCOR BIOMEDICAL LTD.
    Date Cleared
    2003-05-01

    (52 days)

    Product Code
    MID
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA

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

    Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to cardiolipin in human serum.

    Uses:

    The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of autoimmune diseases associated with elevated levels of anti-cardiolipin antibodies including anti-phospholipid syndrome. Levels of these autoantibodies are one indicator in a multifactorial diagnostic regime.

    This device can be used with the HYCOR HY•TEC automated EIA instrument.

    For in vitro diagnostic use only.

    Prescription use

    Device Description

    Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to cardiolipin in human serum.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the Autostat™ II Anti-Cardiolipin IgA ELISA device.

    Unfortunately, this document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

    This indicates that the FDA's decision is based on substantial equivalence to a predicate device, rather than a detailed presentation and review of a specific clinical performance study with acceptance criteria and ground truth validation for this particular device. The document primarily focuses on regulatory approval based on this equivalence and general controls, not on specific performance data from a new clinical study.

    Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, I would need to review the actual 510(k) submission and its supporting documentation, which would contain the performance data and study details.

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