# K161227: VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jul 20, 2016 after 79 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.
5 later devices descend from it; 2 cite it directly.
0 of 13 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 5.

## Most influential descendants
- K172731: VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) (2017), 3 descendants of its own
- K183415: VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) (2019), 2 descendants of its own
- K193572: VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) (2020), 1 descendant of its own
- K211136: VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) (2021), 0 descendants of its own
- K163006: VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) (2017), 0 descendants of its own

## Indications for use
VITEK® 2 AST-Gram Negative Cefepime 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 Cefepime is a quantitative test. Cefepime 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: Enterobacter spp. Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa In vitro data available but clinical significance is unknown: Citrobacter koseri (formerly Citrobacter diversus) Citrobacter freundii Pantoea agglomerans (formerly Enterobacter agglomerans) Klebsiella oxytoca Proteus vulgaris Providencia rettgeri Providencia stuartii Serratia marcescens 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/K161227
Methodology: https://510kreport.com/methodology