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510(k) Data Aggregation

    K Number
    K982100
    Device Name
    IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    1999-12-20

    (553 days)

    Product Code
    CFN
    Regulation Number
    866.5510
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This assay is designed for the in vitro measurement of human IgG3 in serum using the MININEH analyzer as measurement of human 1965 in berail ablig one and in the diagnosis of the

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "IgG and IgG Subclass Nephelometric Diagnostic Test Kits" (Trade Name: Minineph IgG3 Antiserum Device Name). It confirms the device's substantial equivalence to a legally marketed predicate device.

    However, this document does not contain the detailed acceptance criteria and study data requested in your prompt.

    The letter focuses on regulatory clearance, not the technical specifications, performance data, or study methodologies that would typically be found in a 510(k) summary, clinical study report, or a more comprehensive technical document. It mentions that the device is for "in vitro measurement of human IgG3 in serum using the MININEPH analyzer."

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, reported performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

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