LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012291
    Device Name
    HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
    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
    Why did this record match?
    Device Name :

    HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA

    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 BNI. Subcrasses if 2, 3 and innoglobulins aids in the diagnosis of Measurement of chebe immandy ond 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 text is a 510(k) clearance letter from the FDA for an in vitro diagnostic device, "Human IgG Subclass Liquid Reagent Kits." It does not contain any information about acceptance criteria for a device performance, a study to prove these criteria were met, or any details related to AI/algorithm performance.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on specific performance metrics or clinical study results as they would be presented for an AI-powered diagnostic device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1