# K172944: VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Dec 19, 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: 1 (0 Class I)
- 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)
- K161510: VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL), bioMerieux, Inc. (2017) Summary page 5.

## Recalls of this device
- Jan 5, 2026 · Class II · Z-1236-2026: Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identif

## Indications for use
VITEK® 2 Gram Negative Ceftazidime/Avibactam 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 Ceftazidime/Avibactam is a quantitative test. Ceftazidime/Avibactam 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: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa The following in vitro data are available, but clinical significance is unknown: Citrobacter koseri Enterobacter aerogenes Morganella morganii 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/K172944
Methodology: https://510kreport.com/methodology