# K172150: Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Sep 15, 2017 after 60 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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: 4 generations back to K102668 (2010). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170670: Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml), bioMerieux, Inc. (2017) Summary page 5.

## Most influential descendants
- K250856: ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (2025), 0 descendants of its own
- K190154: ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) (2019), 0 descendants of its own

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0846-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in μg/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Ceftazidime/Avibactam has been shown to be active against the Gram negative aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent. Etest® CZA can be used to determine the MIC of Ceftazidime/Avibactam against the microorganisms listed below: 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 rettgeri Providencia stuartii Serratia marcescens

Source page: https://510kreport.com/device/K172150
Methodology: https://510kreport.com/methodology