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

No FDA recalls found in the data synced 6 Oct 2026.

Trade Name

ETEST® Imipenem Relebactam (IRPA)

Model / Reference

543349

Primary DI / UDI-DI

03573026633509

Basic UDI-DI

357302BUDI002211T7

510(k) Number

K250274 ↗

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

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See all devices from Biomerieux S.A. →

• What is the primary purpose of the ETEST Imipenem/Relebactam P. aeruginosa test system, and how does it differ from other antimicrobial susceptibility tests?

  The ETEST Imipenem/Relebactam P. aeruginosa (IRPA) is specifically designed to determine whether *Pseudomonas aeruginosa* isolates are resistant or susceptible to the antibiotic combination of imipenem and relebactam. Unlike other tests, it uses gradient diffusion strips to measure the minimum inhibitory concentration (MIC) of this particular drug pairing, helping clinicians select targeted antimicrobial therapy. This precision aids in combating resistance patterns unique to this bacterial strain and antibiotic combination.

• Is this test system single-use, and if so, what are the implications for handling and cost management in a lab setting?

  Yes, the ETEST Imipenem/Relebactam P. aeruginosa is a single-use test system, meaning each strip is intended for one test only. This design eliminates cross-contamination risks and ensures accurate, reproducible results. For labs, this means managing inventory carefully to avoid waste, but it also simplifies workflows by reducing the need for sterilization or reprocessing between uses. Cost management may require balancing the per-test expense against the reliability of single-use precision.

• What storage requirements apply to the ETEST strips, and how should they be handled to maintain performance?

  The test strips do not require special storage conditions beyond protection from light and moisture. They should be stored in a dry, sealed environment away from direct sunlight or humidity to preserve their integrity. Since they are non-sterile, they do not need refrigeration or sterile packaging handling, but proper labeling and organization are still critical to avoid mix-ups or expiration. Always check the expiration date before use.

• What concentration range does the ETEST Imipenem/Relebactam P. aeruginosa cover, and why is this range important for clinical decision-making?

  The test strips cover a concentration range of 0.008/4 to 128/4 µg/mL for imipenem/relebactam, allowing for precise measurement of bacterial susceptibility across a broad spectrum. This range is critical because it enables clinicians to detect both low-level resistance (where bacteria may survive at higher concentrations) and high-level resistance (where bacteria are unaffected even at elevated doses). Accurate MIC values help tailor treatment to the specific sensitivity profile of the isolate, reducing the risk of treatment failure or unnecessary broad-spectrum antibiotic use.

• How is this device regulated, and what does that mean for labs considering adoption?

  The ETEST Imipenem/Relebactam P. aeruginosa is authorized under FDA 510(k) clearance and IVDR compliance, indicating it meets regulatory standards for safety, effectiveness, and performance as a manual antimicrobial susceptibility test system. For labs, this means the device has undergone validation to ensure its accuracy and reliability for determining susceptibility to imipenem/relebactam in *P. aeruginosa* isolates. Adoption aligns with regulatory expectations for microbiology testing, though labs should verify compatibility with their internal protocols and quality systems.