(90 days)
Not Found
No
The device description outlines a manual technique based on a physical strip and visual interpretation of bacterial growth inhibition. The document makes no mention of AI, machine learning, or deep neural networks.
No.
The device determines the Minimum Inhibitory Concentration (MIC) of antimicrobial agents against microorganisms, which is a diagnostic function to guide treatment rather than directly providing therapy.
Yes
The device determines the Minimum Inhibitory Concentration (MIC) of antimicrobial agents against microorganisms, which is a diagnostic step for assessing bacterial susceptibility and guiding treatment.
No
The device is a physical strip with a predefined antibiotic gradient that transfers into an agar matrix. It relies on visual interpretation of bacterial growth inhibition to determine MIC values, a process that is entirely hardware/physical in nature.
Yes.
The device is used to determine antimicrobial susceptibility and Minimum Inhibitory Concentration (MIC) of microorganisms, which is a diagnostic test performed on cultured biological samples (bacteria on agar media).
Yes
The letter states, "FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP)." This explicitly indicates that the PCCP has been cleared for this device.
Intended Use / 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 Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) is indicated for Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).
The ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) demonstrated acceptable performance with the following microorganism:
• Pseudomonas aeruginosa
Product codes
JWY
Device Description
ETEST® is a thin, inert and non-porous plastic strip carrying the MIC reading scale in μg/mL on one side and a predefined antibiotic gradient on the other side.
When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of μg/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) with a concentration range of 0.008/4-128/4 µg/mL is specially designed and formulated for testing P. aeruginosa.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL) by comparing with the CLSI broth microdilution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The study type consists of external evaluations comparing the ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL) with the CLSI M07-11th Ed (January 2018) broth microdilution reference method.
The sample size for Pseudomonas aeruginosa was 437 strains.
Key results are:
- Essential Agreement (EA) for Pseudomonas aeruginosa: 97.7%
- Category Agreement (CA) for Pseudomonas aeruginosa: 91.1%
- Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) = % of MIC values within ± 1 dilution of the reference method: 97.7%
Category Agreement (CA): 91.1%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter - ETEST Imipenem/Relebactam P. aeruginosa (IRPA)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 30, 2025
bioMerieux, SA
Sophie Quiblier
Regulatory Affairs Specialist
376 Chemin de l'Orme
Marcy L'Etoile, 69280
France
Re: K250274
Trade/Device Name: ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
Regulation Number: 21 CFR 866.1640
Regulation Name: Antimicrobial Susceptibility Test Powder
Regulatory Class: Class II
Product Code: JWY
Dated: January 30, 2025
Received: January 30, 2025
Dear Sophie Quiblier:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new
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K250274 - Sophie Quiblier
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premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
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K250274 - Sophie Quiblier
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803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM)
Chief
General Bacteriology and Antimicrobial Susceptibility Branch
Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K250274
Device Name
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
Indications for Use (Describe)
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 Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) is indicated for Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).
The ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) demonstrated acceptable performance with the following microorganism:
• Pseudomonas aeruginosa
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Page 5
ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL)
A. 510(k) Submission Information:
Submitter's Name: bioMerieux SA
Address: 376 Chemin de l'Orme
69280 Marcy-l'Etoile, FRANCE
Contact Person: Sophie QUIBLIER
Regulatory Affairs Specialist
Phone Number: (314) 731-8666
Date of Preparation: April 28th, 2025
B. Device Name:
Formal/Trade Name: ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL)
Classification Name: 21 CFR 866.1640
Manual Antimicrobial Susceptibility Test Systems
Product Code: JWY
Common Name(s): ETEST® Imipenem/Relebactam P. aeruginosa (IRPA)
ETEST® (IRPA)
C. Predicate Device:
ETEST® Meropenem/Vaborbactam (0.004-64/8 μg/mL) (K183031)
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Page 6
D. Device Description:
ETEST® is a thin, inert and non-porous plastic strip carrying the MIC reading scale in μg/mL on one side and a predefined antibiotic gradient on the other side.
When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of μg/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) with a concentration range of 0.008/4-128/4 µg/mL is specially designed and formulated for testing P. aeruginosa.
E. Intended 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 Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) is indicated for Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).
The ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) demonstrated acceptable performance with the following microorganism:
• Pseudomonas aeruginosa
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F. Summary of the technological characteristics of the new device in comparison to those of the predicate device.
The similarities and differences of ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL) when compared to the predicate device, ETEST® Meropenem/Vaborbactam (MEV) (0.004-64/8 μg/mL) (K183031), are described in the table below:
| Item | ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL) | ETEST® Meropenem/Vaborbactam (MEV) (0.004-64/8 μg/mL) (K183031) |
|---|---|---|
| General Device Characteristic Similarities | ||
| Intended 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 Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) is indicated for Pseudomonas aeruginosa, as recognized by the FDA | 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.
Meropenem/Vaborbactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial |
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| Item | ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL) | ETEST® Meropenem/Vaborbactam (MEV) (0.004-64/8 μg/mL) (K183031) |
|---|---|---|
| Susceptibility Test Interpretive Criteria (STIC). |
The ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) demonstrated acceptable performance with the following microorganism:
• Pseudomonas aeruginosa | agent;
ETEST® MEV can be used to determine the MIC of Meropenem/Vaborbactam against indicated organisms (as listed in differences section) |
| Test Methodology | Quantitative antimicrobial susceptibility test to determine the in vitro susceptibility of microorganisms | Same |
| Inoculum | Suspension of organism | Same |
| Type of test | Quantitative | Same |
| Clinical & Challenge Performance Data | Pseudomonas aeruginosa
EA = 97.7%
CA = 91.1% | Enterobacteriaceae (excluding Proteus mirabilis)
EA=95.8%
CA=99.3% |
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| Item | ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL) | ETEST® Meropenem/Vaborbactam (MEV) (0.004-64/8 μg/mL) (K183031) |
|---|---|---|
| Reproductibility | Best case: 99.6% | |
| Worst Case: 99.6% | Best case: 99,6% | |
| Worst Case: 99,6% | ||
| Quality Control | Results within range>95% of the times tested | Results within range>95% of the times tested |
| Meets Guidance Document Performance Requirements | Yes | Yes |
| Differences | ||
| Antimicrobial Agent | Imipenem/Relebactam | Meropenem/Vaborbactam |
| Concentrations | Imipenem: 0.008 to 128 μg/mL | |
| Relebactam: 4 μg/mL | Meropemen: 0.004 to 64 μg/mL | |
| Vaborbactam: 8 μg/mL | ||
| Indicated organisms | Testing with ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) is indicated for Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). |
The ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) demonstrated acceptable performance with the following microorganism: | Meropenem/Vaborbactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent;
ETEST® MEV can be used to determine the MIC of Meropenem/Vaborbactam against the following microorganisms.
Active both in vitro and in clinical infections: |
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Page 10
| Item | ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL) | ETEST® Meropenem/Vaborbactam (MEV) (0.004-64/8 μg/mL) (K183031) |
|---|---|---|
| • Pseudomonas aeruginosa | o Enterobacter cloacae complex species | |
| o Escherichia coli | ||
| o Klebsiella pneumoniae |
In vitro data are available for the following microorganisms, but clinical significance is unknown:
o Citrobacter freundii
o Citrobacter koseri
o Klebsiella aerogenes
o Klebsiella oxytoca
o Morganella morganii
o Providencia spp.
o Serratia marcescens |
| Breakpoints | P.aeruginosa:
(S/I/R) ≤2/4/≥8 | Enterobacterales:
(S/I/R) ≤4/8/≥16 |
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G. Performance Overview
ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL) demonstrated substantially equivalent performance when compared with the CLSI M07-11th Ed (January 2018) broth microdilution reference method, following rules as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued on August 28, 2009 and following specifications as defined in CLSI M100 34th Ed. (February 2024).
This Premarket Notification (510[k]) presents data in support of ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL) for P. aeruginosa.
External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL) by comparing with the CLSI broth microdilution reference method.
ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL) demonstrated acceptable performance as presented in Table 1 below:
Table 1: Performance Characteristics for ETEST®Imipenem/Relebactam P. aeruginosa (IRPA)
| Strains (N) | % Essential Agreement (EA)a) | % Category Agreement (CA) |
|---|---|---|
| Pseudomonas aeruginosa | 437 | 97.7 |
Notes:
• a) EA = % of MIC values within ± 1 dilution of the reference method.
• b) In the ETEST® Imipenem/Relebactam clinical studies, swabs were used for plate inoculation/streaking and forceps were used for ETEST® strip application. Testing with the optional Inoculator RETRO C80™, Vacuum Pen NEMA C88™ and Applicator SIMPLEX C76™ was not evaluated during the clinical studies.
Reproducibility and Quality Control demonstrated acceptable results.
Conclusion:
The performance data presented in this submission support a substantial equivalence decision. ETEST® Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 μg/mL) is substantially equivalent to ETEST® Meropenem/Vaborbactam (MEV) (0.004-64/8µg/mL) (K183031).
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