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510(k) Data Aggregation

    K Number
    K180330
    Device Name
    Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL
    Manufacturer
    Liofilchem s. r. l.
    Date Cleared
    2018-03-15

    (37 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

    The Linezolid MTS at concentrations of 0.016- 256 ug/mL should be interpreted at 16-20 hours of incubation.

    Linezolid has been shown to be active both clinically and in vitro agamst the non-fastidious bacteria listed below according to the FDA label:

    Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecium (vancomycin resistant isolates only)

    Device Description

    MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

    AI/ML Overview

    The provided text is a 510(k) premarket notification for the Liofilchem MIC Test Strip (MTS) - Linezolid 0.016 - 256 ug/mL. This document describes the device, its intended use, and the regulatory determination of substantial equivalence. It does not contain a detailed study report that proves the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or specific types of comparative effectiveness studies (like MRMC or standalone AI performance).

    Therefore, I cannot extract the requested information to fill in the table and answer the specific questions about a study showing the device meets acceptance criteria, as that level of detail is not present in this regulatory correspondence. This document primarily focuses on the regulatory clearance for the device based on substantial equivalence to a predicate device.

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