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510(k) Data Aggregation

    K Number
    K002139
    Device Name
    ETEST LINEZOLID
    Manufacturer
    AB BIODISK
    Date Cleared
    2000-11-08

    (114 days)

    Product Code
    LTX
    Regulation Number
    866.1620
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    LTX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K992993
    Device Name
    ETEST FOR QUINUPRISTIN/DALFOPRISTIN
    Manufacturer
    AB BIODISK
    Date Cleared
    1999-11-16

    (70 days)

    Product Code
    LTX
    Regulation Number
    866.1620
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    LTX

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

    For In vitro diagnostic use:

    Etest is a quantitative technique for the determination of antimirrohial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in uy/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

    This Etest 510(k) application is for MIC determination of Quinupristin/Dalfopristin in the range of 0.002 - 32 µg/ml with multi-resistant, including Vancomycin resistant, Enteroccoccus faecium and Methicillin-susceptible Staphylococcus aureus.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA approval letter for a medical device (Etest® for Quinupristin/Dalfopristin) and outlines its intended use and regulatory classification. It does not include details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for a device performance study.

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