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510(k) Data Aggregation

    K Number
    K092784
    Device Name
    C. ALBICANS/C. GLABRATA PNA FISH
    Manufacturer
    ADVANDX, INC.
    Date Cleared
    2010-03-12

    (183 days)

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

    C. ALBICANS/C. GLABRATA PNA FISH

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

    C. albicans/C. glabrata PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of C. albicans and/or C. glabrata on smears made from yeast positive blood cultures.

    Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.

    C. albicans/C. glabrata PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. glabrata fungemia.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) substantial equivalence letter for a medical device and therefore does not contain details about specific acceptance criteria, study data, or ground truth establishment for an AI/ML powered device. This type of document primarily confirms that a device is substantially equivalent to a previously marketed device and outlines regulatory responsibilities.

    To provide the requested information, a clinical study report or a premarket submission summary for an AI/ML device would be necessary. The current document is for a traditional diagnostic assay, not an AI/ML system.

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