# K200512: ETEST Plazomicin (PLZ) (0.016-256 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Biomérieux SA
- Decided: May 7, 2020 after 66 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K102668 (2010). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180936: ETEST Telavancin (TLA) (0.002-32 ug/mL), Biomerieux S.A. (2018) Summary page 4.

## Indications for use
ETEST® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in μg/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 against 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

Source page: https://510kreport.com/device/K200512
Methodology: https://510kreport.com/methodology