LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K082823
    Device Name
    HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
    Manufacturer
    THE BINDING SITE GROUP LTD
    Date Cleared
    2010-03-01

    (522 days)

    Product Code
    CFN,OPX,OPY
    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 the in vitro quantification of IgA Kappa (combined a heavy and k light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed IgA multiple myeloma, in conjunction with other clinical and laboratory findings.

    This kit is intended for the in vitro quantification of IgA Lambda (combined a heavy and À light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed IgA multiple myeloma, in conjunction with other clinical and laboratory findings.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification acceptance letter for diagnostic kits, not a study describing the acceptance criteria and performance of an AI-powered device. Therefore, I cannot extract the requested information as it is not present in the document.

    The document pertains to the Hevylite™ Human IgA Kappa Kit and Hevylite™ Human IgA Lambda Kit for use on Siemens BN™ II systems, which are in vitro diagnostic devices for quantifying IgA Kappa and IgA Lambda concentrations in human serum. These are laboratory assay kits, not AI-powered devices.

    To answer your request, I would need a document detailing a study on an AI-powered device, including its acceptance criteria and performance evaluation.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1