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510(k) Data Aggregation

    K Number
    K120901
    Device Name
    HUMAN IGA CSF KIT FOR USE ON SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2013-05-30

    (430 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 IGA CSF KIT FOR USE ON SPAPLUS

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

    Human IgA CSF Kit for use on SPAPLUS is intended for the quantitative measurement of human IgA 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 document is a 510(k) clearance letter from the FDA for a medical device called "Human IgA CSF Kit for Use on SPAplus". It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, based on its intended use for the quantitative measurement of human IgA in cerebrospinal fluid (CSF) samples using the SPAPLUS analyzer to aid in assessing the body's ability to resist infectious disease.

    Therefore, I cannot provide the requested information from the given text.

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