# K163563: VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Mar 13, 2017 after 84 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: 7 generations back to K032788 (2003). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121546: Vitek 2 Gram Negative Doxycycline, bioMerieux, Inc. (2012) Summary page 4.

## Most influential descendants
- 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 (2023), 0 descendants of its own

## Indications for use
VITEK® 2 Gram Negative Gentamicin 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 Gram Negative Gentamicin is a quantitative test. Gentamicin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections Citrobacter species Enterobacter species Escherichia coli Klebsiella species Proteus species Serratia species Pseudomonas aeruginosa The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

Source page: https://510kreport.com/device/K163563
Methodology: https://510kreport.com/methodology