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510(k) Data Aggregation

    K Number
    K020595
    Device Name
    XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
    Manufacturer
    XENOTOPE DIAGNOSTICS, INC.
    Date Cleared
    2003-02-20

    (363 days)

    Product Code
    JWZ
    Regulation Number
    866.2660
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01

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

    The Xenotope Diagnostics' Inc. XenoStrip™-Tv Trichomonas Cassette Test is intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "XenoStrip-TVTM Trichomonas Cassette Test". It does not contain information about acceptance criteria, study details, or performance data for the device. The letter primarily states that the device has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    Therefore, I cannot provide the requested information from this document.

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