# K223478: VITEK® 2 AST-Gram Negative Plazomicin (=0.5 -  =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 -  =16 µg/mL); VITEK® 2 AST-GN Plazomicin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 16, 2023 after 90 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K032788 (2003). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163563: VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL), bioMerieux, Inc. (2017) Summary page 4.

## Indications for use
VITEK® 2 AST-Gram Negative Plazomicin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Plazomicin is a quantitative test. Plazomicin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Enterobacter cloacae In vitro data are available, but their clinical significance is unknown: Citrobacter freundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Proteus vulgaris Serratia marcescens The VITEK® 2 Gram-Negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.

Source page: https://510kreport.com/device/K223478
Methodology: https://510kreport.com/methodology