# K250856: ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Biomérieux
- Decided: Jun 12, 2025 after 83 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K102668 (2010). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172150: Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL), bioMerieux, Inc. (2017) Summary page 11.

## Indications for use
ETEST is a manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. 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 tested on agar media after overnight incubation. Testing with ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 μg/mL) is indicated for Enterobacterales, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 μg/mL) demonstrated acceptable performance with the following microorganisms: • Enterobacterales: ◦ Escherichia coli ◦ Klebsiella pneumoniae ◦ Klebsiella aerogenes ◦ Citrobacter freundii complex ◦ Citrobacter koseri ◦ Enterobacter cloacae complex ◦ Proteus mirabilis ◦ Proteus vulgaris ◦ Morganella morganii ◦ Providencia stuartii ◦ Serratia marcescens

Source page: https://510kreport.com/device/K250856
Methodology: https://510kreport.com/methodology