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510(k) Data Aggregation

    K Number
    K993633
    Device Name
    SYNTHETIC VDRL ANTIGEN
    Manufacturer
    CENTERS FOR DISEASE CONTROL AND PREVENTION
    Date Cleared
    2000-02-23

    (119 days)

    Product Code
    GMQ
    Regulation Number
    866.3820
    Type
    Traditional
    Panel
    Microbiology (MI)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHETIC VDRL ANTIGEN

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

    Synthetic Venereal Disease Research Laboratory (VDRL) antigen is intended for use in the qualitative and quantitative VDRL slide tests for the detection of IgM and IgG nontreponemal antibodies in the serum or cerebrospinal fluid of persons with syphilis.

    Device Description

    Synthetic VDRL Antigen

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA to Dr. Victoria Pope regarding the 510(k) clearance of the "Synthetic VDRL Antigen" device. It confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory obligations.

    The document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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