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510(k) Data Aggregation

    K Number
    K150526
    Device Name
    Optilite IgG4 Kit
    Manufacturer
    THE BINDING SITE GROUP LTD
    Date Cleared
    2015-05-30

    (89 days)

    Product Code
    CFN
    Regulation Number
    866.5510
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Optilite IgG4 Kit

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Optilite® IgG4 Kit is intended for the quantitative in vitro measurement of IgG4 in serum using the Binding Site Optilite analyser. Measurement of this immunoglobulin is an aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test result should be used in conjunction with other laboratory and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Optilite® IgG4 Kit, which confirms that the device is substantially equivalent to a predicate device. It specifies the intended use of the device but does not detail the acceptance criteria, study design, sample sizes, ground truth establishment, or any information about AI assistance or human reader performance.

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