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510(k) Data Aggregation

    K Number
    K993554
    Device Name
    YEASTEST
    Manufacturer
    DIAGNOSTIC MARKERS, INC.
    Date Cleared
    2000-02-10

    (113 days)

    Product Code
    JXB
    Regulation Number
    866.2660
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit is used for the detection of catalase-peroxidase activity in Candida species from vaginal specimens.

    Device Description

    Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) clearance for the "YeasTest™ Diagnostic Kit." This document does not contain any information about acceptance criteria, device performance metrics, study designs (sample sizes, ground truth establishment, expert qualifications, or adjudication methods), or comparative effectiveness studies (MRMC or standalone).

    The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and compliance. The "Indications For Use" section states that the device is "used for the detection of catalase-peroxidase activity in Candida species from vaginal specimens," but provides no data or performance specifications.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance based on the provided input.

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