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

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • Ongoing Z-0849-2023 FDA Class II ·initiated 9 Nov 2022

  As the temperature and time out of range was exceeded, product performances cannot be guaranteed

• • Terminated Z-2226-2021 FDA Class II ·initiated 24 Jun 2021

  Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.

Trade Name

ETEST® Imipenem/Relebactam (IPR)

Model / Reference

542988

Primary DI / UDI-DI

03573026624019

Basic UDI-DI

357302BUDI002013SZ

Unit of Use DI

03573026624286

510(k) Number

K191953 ↗

FDA Product Code

JWY

EMDN Code

W0104080501 Mic systems - dilution methods (incl. e-test)

Device Class

Class B EUDAMED

Class II 510(k)

Regulation

21 CFR Part 866.1640

EU market of registration

France

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• ETEST Delafloxacin (DFX) (0.002-32 µg/mL)

  Class II

  CE/IVDR FDA 510(k) K192738 Active Cleared 26 Nov 2019 +1authorizations

• ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)

  Class II

  CE/IVDR FDA 510(k) K250274 Active Cleared 30 Apr 2025

• ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

  Class II

  CE/IVDR FDA 510(k) K183031 Active Cleared 11 Jan 2019

• Etest Ceftaroline (0.002 - 32ug/ml)

  Class II

  FDA 510(k) K151873 Active Cleared 7 Oct 2015

• ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

  Class II

  CE/IVDR FDA 510(k) K190154 Active Cleared 1 May 2019

• Vidas C Difficile Gdh

  Class I

  FDA 510(k) K132010 Active Cleared 9 Oct 2013

See all devices from Biomerieux S.A. →

• What is the ETEST Imipenem/Relebactam (IPR) used for in a clinical setting?

  The ETEST Imipenem/Relebactam (IPR) is a manual antimicrobial susceptibility test system used in microbiology laboratories to determine how susceptible bacteria are to imipenem when combined with relebactam. It measures the minimum inhibitory concentration (MIC) by applying a gradient of imipenem (ranging from 0.002 to 32 µg/mL) alongside a fixed relebactam concentration (4 µg/mL) on agar media. This helps guide treatment decisions by identifying whether bacteria will respond to this antibiotic combination.

• How is the ETEST Imipenem/Relebactam (IPR) supplied, and is it reusable?

  The ETEST Imipenem/Relebactam (IPR) is supplied as a single-use plastic strip with a predefined antibiotic gradient. Since it is designed for manual application to agar media and is labeled as single-use, it cannot be reused. Each strip is intended for one test to ensure accuracy and sterility.

• What regulatory pathways does the ETEST Imipenem/Relebactam (IPR) follow, and where is it cleared?

  The ETEST Imipenem/Relebactam (IPR) is cleared under the FDA’s 510(k) pathway (K191953) and complies with the In Vitro Diagnostic Regulation (IVDR). It is classified as a Class II device (device class 2) and falls under the product code JWY, which is associated with manual antimicrobial susceptibility test systems. The device is intended for in vitro diagnostic use.

• How does the ETEST Imipenem/Relebactam (IPR) differ from other antimicrobial susceptibility test systems?

  Unlike some automated systems, the ETEST Imipenem/Relebactam (IPR) is a manual, thin plastic strip that requires no external power or software. It uses a gradient of imipenem (0.002–32 µg/mL) combined with a fixed relebactam concentration (4 µg/mL) to measure MICs directly on agar plates. This makes it a straightforward, hands-on solution for microbiology labs without the need for specialized equipment.