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    K Number
    K024195
    Device Name
    MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
    Manufacturer
    CORGENIX, INC.
    Date Cleared
    2003-01-03

    (14 days)

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

    MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT

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

    The REAADS IgA Anti-PhosphatidyIserine Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgA anti-phosphatidylserine antibodies in human serum or plasma in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a diagnostic test kit. It does not contain the detailed study information required to answer the questions about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment. The document only confirms that the device is substantially equivalent to a legally marketed predicate device.

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

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