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510(k) Data Aggregation
K Number
K200512Device Name
ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
Manufacturer
bioMérieux S.A.
Date Cleared
2020-05-07
(66 days)
Product Code
JWY
Regulation Number
866.1640Why did this record match?
Applicant Name (Manufacturer) :
bioMérieux S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ETEST® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Plazomicin has been shown to be active against most isolates of the bacteria listed below according to the FDA label for this antimicrobial agent.
ETEST® PLZ can be used to determine the MIC of Plazomicin aqainst the following microorganisms:
Active both in vitro and in clinical infections:
- Escherichia coli
- Klebsiella pneumoniae
- Proteus mirabilis
- Enterobacter cloacae
In vitro data are available for the following microorganisms, but clinical significance is unknown:
- Citrobacter freundii
- Citrobacter koseri
- Klebsiella (Enterobacter) aerogenes
- Klebsiella oxytoca
- Morganella morganii
- Proteus vulgaris
- Providencia stuartii
- Serratia marcescens
Device Description
ETEST® is a thin, inert and non-porous plastic strip carrying the MIC reading scale in µg/mL on one side and a predefined antibiotic gradient on the other side.
When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.
ETEST® Plazomicin contains a range of plazomicin from 0.016 to 256 ug/mL.
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