LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K191908
    Device Name
    MTS Imipenem 0.016-256 µg/mL
    Manufacturer
    Liofilchem s.r.l.
    Date Cleared
    2019-09-04

    (50 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MTS Imipenem 0.016-256 µg/mL

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

    MTS (MIC Test Strip) Imipenem 0.016 - 256 µg/mL 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 µg/mL against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Imipenem at concentrations of 0.016 - 256 µg/mL should be interpreted at 16-20 hours of incubation.

    Imipenem has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:

    Gram-negative bacteria

    Citrobacter koseri Citrobacter freundii Enterobacter asburiae Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Proteus vulgaris Providencia rettgeri Serratia marcescens Acinetobacter baumannii Pseudomonas aeruginosa

    Imipenem has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label:

    Gram-negative bacteria

    Providencia stuartii

    Device Description

    MTS (MIC Test Strip) Imipenem 0.016 - 256 µg/mL 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 µg/mL against bacteria as tested on agar media using overnight incubation and manual reading procedures.

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed study information I need to fulfill your request. The document is an FDA 510(k) clearance letter for the MTS Imipenem device, which indicates its intended use and lists bacterial species it's effective against. However, it does not include:

    • A table of actual acceptance criteria or reported device performance against those criteria.
    • Details about sample sizes for test sets, data provenance, or training sets.
    • Information on expert qualifications, ground truth establishment, or adjudication methods for studies.
    • Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.

    Therefore, I cannot provide the requested information based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1