# K161437: VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 16, 2017 after 268 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)
- K152075: VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL), bioMerieux, Inc. (2016) Summary page 5.

## Indications for use
VITEK® 2 Gram Negative Cefotaxime 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 Cefotaxime is a quantitative test. Cefotaxime 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 clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter spp. Escherichia.coli Klebsiella spp. (including Klebsiella pneumoniae) Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Serratia marcescens In vitro data available but clinical significance is unknown: Providencia spp. Salmonella spp. (including Salmonella typhi) The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System 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/K161437
Methodology: https://510kreport.com/methodology