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510(k) Data Aggregation

    K Number
    K042152
    Device Name
    BINDING SITE IGG SUBLCASS OLYMPUS KITS
    Manufacturer
    THE BINDING SITE
    Date Cleared
    2004-11-22

    (105 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 human IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the Olympus AU series analysers. 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

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for an IVD device, the "Binding Site Human IgG Subclass Kit for use on the Olympus AU Series of Instruments." It does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement, as this is typically found in the 510(k) summary or full submission.

    Therefore, I cannot extract the requested information from the provided text. The document confirms that the device has been cleared based on substantial equivalence to a predicate device, but it does not detail the specific studies or performance metrics used to establish that equivalence.

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