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K Number
K180886
Device Name
Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
Manufacturer
Liofilchem s. r. l.
Date Cleared
2018-05-18

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

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

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

Gram-negative bacteria Escherichia coli Klebsiella pneumoniae Enterobacter cloacae Pseudomonas aeruginosa

Delafloxacin has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug label: Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Proteus mirabilis

Device Description

Not Found

AI/ML Overview

This document does not contain the information required to complete this request. The provided text is a 510(k) summary letter and an "Indications for Use" statement for the Liofilchem MIC Test Strip (MTS), Delafloxacin. It describes the device, its intended use, and the regulatory determination by the FDA (substantial equivalence to a predicate device).

However, it does not include any details about:

  • Acceptance criteria for performance metrics.
  • Results of a study proving the device meets acceptance criteria.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Number or qualifications of experts for ground truth.
  • Adjudication methods.
  • Whether MRMC or standalone studies were performed, or their results.
  • Type of ground truth used.
  • How ground truth for the training set was established.

Therefore, I cannot fulfill your request based solely on the provided text. To answer your questions, I would need a clinical study report, a comprehensive premarket notification (510(k)) submission document, or a similar technical report for the device.

§ 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).