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510(k) Data Aggregation

    K Number
    K081674
    Device Name
    BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2008-10-15

    (120 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology (IM)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA

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

    These assays are designed for the in-vitro measurement of specific IgG or IgA antibodies against a modified gliadin peptide (MGP) in human serum, as an aid in the diagnosis of coeliac disease in conjunction with other clinical and laboratory findings.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The document is an FDA 510(k) clearance letter for the BINDAZYME™ Human Anti-Gliadin (MGP) IgG/IgA EIA Kits, which indicates that the device has been found substantially equivalent to a legally marketed predicate device.

    However, the letter does not include:

    • A table of acceptance criteria and reported device performance.
    • Information about specific studies conducted to prove the device meets acceptance criteria.
    • Details on sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for either test or training sets.

    This type of information is typically found in the 510(k) submission itself, which is a much more comprehensive document than the clearance letter provided. The clearance letter is merely the FDA's decision based on its review of that submission.

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