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    K Number
    K042579
    Device Name
    BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
    Manufacturer
    THE BINDING SITE
    Date Cleared
    2005-07-28

    (309 days)

    Product Code
    NBT
    Regulation Number
    866.5785
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT

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

    This assay is intended for the in vitro semi-quantitative measurement of ASCA IgA anti-Saccharomyces cerevisiae antibody in human serum. The presence of ASCA may aid in the diagnosis of patients with Crohn's disease. The test results should be used in conjunction with clinical findings and other laboratory tests. The ASCA IgA should not be used alone as a screening test for ASCA. ASCA IgA test should be used to complement, but not to replace or to substitute the ASCA IgG antibody test since some Crohn's disease subgroup patients may not have IgA antibodies.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA. It approves a device based on substantial equivalence to an existing predicate device, but it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information from this document. The letter is a regulatory approval, not a scientific study report.

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