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510(k) Data Aggregation

    K Number
    K022083
    Device Name
    HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2002-07-16

    (20 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 range of kits is intended for quantifying IgG Subclasses 1, 2, 3 & 4 immunoglobulins in serum on the Beckman Immage Analyzer.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

    The document is an FDA 510(k) premarket notification letter for a device called "Human IgG Subclass Kit for Use on the Beckman Immage Analyser." It states that the device is substantially equivalent to a legally marketed predicate device.

    The information primarily concerns regulatory approval, product codes, regulation numbers, and contact information for the FDA. It does not contain the technical details of a study or acceptance criteria as requested in your prompt.

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