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510(k) Data Aggregation

    K Number
    K120749
    Device Name
    HUMAN IGG 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
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Human IqG CSF Kit for use on SPAPLUS is intended for the quantitative measurement of human IgG 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

    This is a 510(k) clearance letter from the FDA for a diagnostic kit, not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and AI performance metrics is not applicable and cannot be extracted from this document.

    The document describes a "Human IgG CSF Kit for Use on SPAplus" which is intended for the quantitative measurement of human IgG in cerebrospinal fluid (CSF) samples. The FDA has determined this device is "substantially equivalent" to legally marketed predicate devices. This type of clearance does not involve clinical studies with human readers or AI algorithms as the primary subject of evaluation in the way your prompt describes.

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