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510(k) Data Aggregation

    K Number
    K120750
    Device Name
    HUMAN IGM CSF KIT
    Manufacturer
    THE BINDING SITE GROUP LTD
    Date Cleared
    2013-05-17

    (431 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 IGM CSF KIT

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

    Human IgM CSF kit for use on SPAPLUS is intended for the quantitative measurement of human IgM in cerebrospinal fluid (CSF) samples using the SPAPLUS analyser. Measurement of this immunoglobulin aids in the assessment of the body's lack of ability to resist infectious disease in conjunction with other clinical and laboratory findings.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to The Binding Site Group Ltd. regarding their "Human IgM CSF Kit for Use on SPAplus." This document primarily addresses the FDA's "substantial equivalence" determination for the device, and does not contain the detailed information about acceptance criteria, specific study design elements (like sample size for test/training sets, experts, adjudication methods, or MRMC studies), or the ground truth establishment that would be present in a comprehensive study report or a 510(k) submission summary itself.

    Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval letter, not a scientific study report.

    To provide the requested details, a different document, such as the actual 510(k) submission summary or a performance study report, would be needed.

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