# K170670: Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: May 31, 2017 after 86 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: 3 generations back to K102668 (2010). 3 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K151873: Etest Ceftaroline (0.002 - 32ug/ml), Biomerieux S.A. (2015) Summary page 5.

## Most influential descendants
- K172150: Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) (2017), 2 descendants of its own
- 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-0841-2023: 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. Etest® Ceftolozane / Tazobactam has been shown to be active against the Gram negative aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent: Active both in vitro and in clinical infections: 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 Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii Serratia liquefaciens Serratia marcescens

Source page: https://510kreport.com/device/K170670
Methodology: https://510kreport.com/methodology