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K Number
K172109
Device Name
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
Manufacturer
Liofilchem s. r. l.
Date Cleared
2017-09-27

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

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

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

Staphylococcus aureus

Device Description

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minibitory 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) summary for the Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256μg/mL, an antimicrobial susceptibility test. It details the FDA's substantial equivalence determination. However, the document does not contain the acceptance criteria, the study details proving the device meets those criteria, or any information about sample sizes, ground truth establishment, expert involvement, or MRMC studies.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval and indications for use, not the technical study results.

§ 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).