LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K083074
    Device Name
    AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
    Manufacturer
    ADVANDX, INC.
    Date Cleared
    2009-07-24

    (282 days)

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

    AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT

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

    E. faecalis/OE PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and the detection of selected other enterococci (OE) on smears made from positive blood cultures containing Grampositive cocci in pairs and chains observed on Gram stain.

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

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "E. faecalis PNA FISH® Culture Identification Kit". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot fulfill your request for information about acceptance criteria and supporting studies based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1