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510(k) Data Aggregation

    K Number
    K012295
    Device Name
    HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2001-08-20

    (31 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 kit is intended for quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the BNII. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

    Device Description

    Human IgG Subclass Liquid Reagent Kits (for use on the Behring BNII Analyser)

    AI/ML Overview

    The provided document is an FDA clearance letter for a medical device called "Human IgG Subclass Liquid Reagent Kits". This document primarily focuses on the regulatory approval for marketing the device based on substantial equivalence to a predicate device. It does not contain the detailed information necessary to answer your questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for a performance study.

    Typically, such information would be found in the 510(k) submission itself, or in supporting technical documentation referenced within the submission, but not in the clearance letter.

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

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