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K Number
K183527
Device Name
MTS Ciprofloxacin 0.002 - 32 µg/mL
Manufacturer
Liofilchem s. r. l.
Date Cleared
2019-03-19

(90 days)

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

The MTS™ (MIC Test Strip) Ciprofloxacin 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTS™ consists of specialized paper impremated with a pre-defined concentration eradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents as tested on agar media using overnight incubation and manual reading procedures. MTS™ Ciprofloxacin at concentrations of 0.002 - 32 ug/mL should be interpreted at 16-20 hours of incubation. MTS™ Ciprofloxacin can be used to determine the MIC of ciprofloxacin against the following bacteria. Ciprofloxacin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved abel: Gram-negative bacteria Citrobacter freundii Citrobacter koseri Enterobacter cloacae Escherichia coli Morganella morganii Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Serratia marcescens

Device Description

MTS™ consists of specialized paper impremated with a pre-defined concentration eradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents as tested on agar media using overnight incubation and manual reading procedures.

AI/ML Overview

This is a 510(k) clearance letter for the MTS™ Ciprofloxacin 0.002-32 µg/mL, an antimicrobial susceptibility test. The letter indicates substantial equivalence to a predicate device and includes the "Indications for Use" statement. However, it does not contain the detailed information required to fulfill your request regarding acceptance criteria and the study proving device performance.

Specifically, the document does not include:

  • A table of acceptance criteria and reported device performance.
  • Sample size used for the test set or data provenance.
  • Number and qualifications of experts for ground truth.
  • Adjudication method for the test set.
  • Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
  • Information on a standalone performance study.
  • The type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

This document is primarily an FDA clearance letter outlining the regulatory approval and intended use for the device, rather than a detailed study report. To get the information you requested, you would typically need to refer to the full 510(k) submission summary or a separate clinical/technical study report.

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).