# K191953: ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux S.A.
- Decided: Aug 22, 2019 after 31 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K183031 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183031: ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL), Biomerieux S.A. (2019) Summary page 3.

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0849-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- Jun 24, 2021 · Class II · Z-2226-2021: Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.

## Indications for use
ETEST® is a manual, quantitative technique for 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. Imipenem/Relebactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent. ETEST® IPR can be used to determine the MIC of Imipenem/Relebactam against the following microorganisms: Active both in vitro and in clinical infections: • Citrobacter freundii • Enterobacter cloacae • Escherichia coli • Klebsiella aerogenes • Klebsiella oxytoca • Klebsiella pneumoniae • Pseudomonas aeruginosa

Source page: https://510kreport.com/device/K191953
Methodology: https://510kreport.com/methodology