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K Number
K181889
Device Name
MTS Penicillin 0.002- 32 µg/mL
Manufacturer
Liofilchem s. r. l.
Date Cleared
2018-09-13

(62 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® MTS™ (MIC Test Strip) Penicillin 0.002-32 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 minibitory concentration (MC) in us/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The MTSTM Penicillin at concentrations of 0.002 - 32 ug/mL should be interpreted at 20-24 hours of incubation for Streptococcus spp.

MTS™ Penicillin can be used to determine the MIC of penicillin against the following bacteria. Penicillin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:

Streptococcus pneumoniae Streptococcus pyogenes (Group A ) Streptococcus dysgalactiae (Groups C & G) Streptococcus anginosus (Groups C & G) Streptococcus constellatus (Groups C & G) Streptococcus intermedius (Groups C & G)

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 (MC) in us/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 marketing authorization for an antimicrobial susceptibility test. It does not contain information regarding studies to prove acceptance criteria for an AI/ML device. Therefore, I cannot extract the requested information.

§ 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).