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    K Number
    K092450
    Device Name
    HUMAN IGD KIT FOR USE ON SPAPLUS
    Manufacturer
    THE BINDING SITE
    Date Cleared
    2009-12-28

    (140 days)

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

    HUMAN IGD KIT FOR USE ON SPAPLUS

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

    This kit is intended for measuring human immunoglobulin D (IgD) in serum as an aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test result is to be used in conjunction with other clinical and laboratory findings.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA clearance letter for a medical device (Human IgD Kit for use on SPAplus). It does not include information about acceptance criteria, device performance results, study details, or ground truth establishment. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

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