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510(k) Data Aggregation

    K Number
    K171906
    Device Name
    Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL
    Manufacturer
    Liofilchem s. r. l.
    Date Cleared
    2017-08-01

    (36 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 the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

    The Delaf loxacin MTS at concentrations of 0.002-32 ug/mL should be interpreted at 16-20 hours of incubation.

    The non-fastidious bacteria that have been shown to be active both clinically and in vitro against Delaf loxacin according to the FDA label are: Staphylococcus aureus (including methicillin-resistant and methicillin susceptible isolates) Staphylococcus haemolyticus Staphylococcus lugdunensis Enterococcus faecalis

    Device Description

    MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum 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

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Liofilchem MIC Test Strip (MTS) - Delafloxacin 0.002 - 32 µg/ml". It is a device used for in vitro determination of antimicrobial susceptibility of bacteria.

    The provided text does not contain detailed information about the acceptance criteria, the study design, or specific performance metrics of the device. It primarily outlines the regulatory approval process and general information about the device's intended use.

    Therefore, I cannot provide the requested information from the given text. The text does not include:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets, data provenance, or details about training sets.
    • Information on expert panel size, qualifications, or adjudication methods for ground truth.
    • Details about MRMC studies, effect sizes, or standalone algorithm performance.
    • Specifics on how ground truth was established for either test or training sets.
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