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510(k) Data Aggregation

    K Number
    K121991
    Device Name
    ENTEROCOCCUS QUICKFISH BC
    Manufacturer
    ADVANDX, INC.
    Date Cleared
    2013-01-07

    (185 days)

    Product Code
    OAH
    Regulation Number
    866.3740
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENTEROCOCCUS QUICKFISH BC

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

    Enterococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and/or the detection of selected other enterococci on smears prepared from positive blood cultures containing grampositive cocci in pairs and chains observed on Gram stain.

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

    Enterococcus QuickFISH BC is indicated in an aid in the diagnosis of bacteremia caused by enterococci.

    Device Description

    Enterococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay

    AI/ML Overview

    This document is a 510(k) clearance letter for the Enterococcus QuickFISH BC device. It does not contain the acceptance criteria or a study that proves the device meets specific performance acceptance criteria.

    The letter primarily covers:

    • The FDA's determination of substantial equivalence for the device.
    • Regulatory information regarding the device's classification and applicable regulations.
    • The intended use statement for the device.

    Therefore, I cannot provide the requested information based on the provided text. The document acts as an approval notice, not a detailed performance study report.

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