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510(k) Data Aggregation

    K Number
    K013079
    Device Name
    REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
    Manufacturer
    CORGENIX, INC.
    Date Cleared
    2001-09-28

    (14 days)

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

    REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT

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

    The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semiquantitation of IgA anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

    The REAADS IgA anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the "REAADS IgA anti-B2GPI Test Kit." It confirms the device's substantial equivalence to a legally marketed predicate device but does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria.

    Therefore, I cannot provide the requested information based on the given text.

    The document primarily focuses on regulatory clearance and does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Information on experts, adjudication methods, or ground truth establishment.
    4. Details of MRMC comparative effectiveness or standalone studies.
    5. Sample size or ground truth establishment for a training set.
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