ETEST® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic 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.

Sulbactam/Durlobactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent.

ETEST® SUD can be used to determine the MIC of Sulbactam/Durlobactam against the following microorganisms:

• Acinetobacter baumannii-calcoaceticus complex

Device Description

ETEST® is a thin, inert and non-porous plastic strip carrying the MIC reading scale in us/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 ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.

ETEST® Sulbactam/Durlobactam contains a range of Sulbactam from 0.004 to 64 µg/mL, overlaid with a fixed concentration of 4 µg/mL of Durlobactam.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the ETEST® Sulbactam/Durlobactam (SUD) device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (ETEST® Sulbactam/Durlobactam)
Essential Agreement (EA)	97.7%
Category Agreement (CA)	98.4%
Reproducibility (Best-case)	99.5%
Reproducibility (Worst-case)	99.5%
Quality Control	Results within expected range > 95% of the time
Meets Guidance Document Performance Requirements	Yes

Note: The document states that ETEST® Sulbactam/Durlobactam (SUD) demonstrated substantially equivalent performance compared with the CLSI M07-11th Ed (January 2018) broth microdilution reference method, following rules from the FDA Class II Special Controls Guidance Document and specifications in CLSI M100 330 (March 2023).

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): 562 strains of Acinetobacter baumannii-calcoaceticus complex.
- Data Provenance: The document states "External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains." This suggests a combination of retrospective (stock clinical isolates) and potentially prospective (fresh clinical isolates) data. The country of origin is not explicitly mentioned but is likely multi-site given the nature of such evaluations for regulatory clearance.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document implies that the CLSI broth microdilution reference method was used as the ground truth. This method is a standardized laboratory procedure and does not typically involve "experts" in the sense of human readers adjudicating images or cases. Instead, it relies on precise technical execution and interpretation according to established CLSI guidelines. Therefore, the concept of a number of experts and their qualifications doesn't directly apply in the same way it would for imaging diagnostics. The "experts" in this context would be the technicians performing the reference method and interpreting the results according to CLSI standards.
Adjudication Method for the Test Set:
- Not applicable as the ground truth is established by a standardized laboratory reference method (CLSI broth microdilution), not human adjudication. The performance metrics (EA, CA) are calculated by comparing the device's MIC values to those obtained from the reference method.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic devices where human readers interpret results, and the study would assess how AI assistance impacts their performance. For antimicrobial susceptibility testing (AST) devices like ETEST®, the comparison is between the automated/manual device and a standardized reference method.
If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- Yes, the performance characteristics (Essential Agreement and Category Agreement) are presented for the ETEST® device in standalone mode, comparing its results directly to the CLSI broth microdilution reference method. While ETEST® is a manual technique, its performance evaluation is based on its ability to produce MIC values that align with the reference method. The note about "swabs were used for plate inoculation/streaking and forceps were used for ETEST® strip application" and that "Testing with the optional Inoculator RETRO C80™, Vacuum Pen NEMA C88™, and Applicator SIMPLEX C76™ was not evaluated" confirms that the reported performance reflects the manual ETEST® process itself, without additional automated assistance that might change interpretation.
The Type of Ground Truth Used:
- Standardized Laboratory Reference Method: The ground truth was established using the CLSI M07-11th Ed (January 2018) broth microdilution reference method. This is considered the gold standard for antimicrobial susceptibility testing.
The Sample Size for the Training Set:
- The document does not explicitly state the sample size for a "training set." For an AST device like ETEST®, "training" would typically refer to the development and internal validation phases before external clinical evaluations. The information provided focuses on the performance evaluation using the specified test set.
How the Ground Truth for the Training Set Was Established:
- As no specific "training set" is detailed in this regulatory summary, the method for establishing ground truth for such a set is not provided. However, it can be inferred that any internal development or validation would also rely on comparisons to established reference methods (like CLSI broth microdilution) for consistency.

Summary

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October 5, 2023

bioMérieux Sophie Quiblier Regulatory Affairs Specialist 376 Chemin de l'Orme Marcy-l'Etoile, 69280 France

Re: K232395

Trade/Device Name: ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 ug/mL), ETEST® SUD Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: August 8, 2023 Received: August 9, 2023

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 (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 located 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.

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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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. D(ABMM), F(AAM) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K232395

Device Name

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 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. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ¿g/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation.

Sulbactam/Durlobactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent.

ETEST® SUD can be used to determine the MIC of Sulbactam/Durlobactam against the following microorganisms:

• Acinetobacter baumannii-calcoaceticus complex

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 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:	+33 (0)4 78 87 75 71
Date of Preparation:	August 8th, 2023

B. Device Name:

Formal/Trade Name:	ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL)
Classification Name:	21 CFR 866.1640Manual Antimicrobial Susceptibility Test SystemsProduct Code: JWY
Common Name(s):	ETEST® Sulbactam/Durlobactam; ETEST® SUD
C. Predicate Device:(K183031)	ETEST® Meropenem/Vaborbactam (0.004/8-64/8 µg/mL)

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D. Device Description:

ETEST® is a thin, inert and non-porous plastic strip carrying the MIC reading scale in us/mL on one side and a predefined antibiotic gradient on the other side.

ETEST® Sulbactam/Durlobactam contains a range of Sulbactam from 0.004 to 64 µg/mL, overlaid with a fixed concentration of 4 µg/mL of Durlobactam.

E. Intended 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 ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation.

Sulbactam/Durlobactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent.

ETEST® SUD can be used to determine the MIC of Sulbactam against the following microorganisms:

Active both in vitro and in clinical infections:

0 Acinetobacter baumanii-calcoaceticus complex

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F. Summary of the technological characterictics of the new device in comparison to those of the predicate device.

The similarities and differences of ETEST® Sulbactam/Durlobactam (SUD) when compared to the predicate device, ETEST® Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) (K183031), are described in the table below:

	Similarities
	Test Device	Predicate Device
Intended Use	ETEST®Sulbactam/Durlobactam (SUD)(0.004/4-64/4 µg/mL)	ETEST®Meropenem/Vaborbactam(MEV) (0.004/8-64/8 µg/mL)(K183031)
	ETEST® is a manual,quantitative technique for thedetermination of antimicrobialsusceptibility of non-fastidiousGram-negative andGram-positive aerobic bacteriaand fastidious bacteria. Thesystem comprises a predefinedantibiotic gradient which isused to determine the MinimumInhibitory Concentration (MIC,in µg/mL) of differentantimicrobial agents againstmicroorganisms tested on agarmedia after overnightincubation.	ETEST® is a manual,quantitative technique fordetermination of antimicrobialsusceptibility of non-fastidiousGram-negative and Gram-positive aerobic bacteria andfastidious bacteria. The systemcomprises a predefinedantibiotic gradient which isused to determine the MinimumInhibitory Concentration (MIC,in µg/mL) of differentantimicrobial agents againstmicroorganisms tested on agarmedia after overnightincubation.
	Sulbactam/Durlobactam hasbeen shown to be active againstthe aerobic microorganismslisted below according to the	Meropenem/Vaborbactam hasbeen shown to be active againstthe Gram-negative aerobicmicroorganisms listed below
	Test Device	Predicate Device
	FDA label for this antimicrobial agent.	according to the FDA label for this antimicrobial agent;
	ETEST® SUD can be used to determine the MIC of Sulbactam/Durlobactam against the following microorganisms:	ETEST® MEV can be used to determine the MIC of Meropenem/Vaborbactam against the following microorganisms.
	Active both in vitro and in clinical infections:	Active both in vitro and in clinical infections:
	Acinetobacter baumanii-calcoaceticus complex	Enterobacter cloacae complex species Escherichia coli Klebsiella pneumoniae
		In vitro data are available for the following microorganisms, but clinical significance is unknown:
		Citrobacter freundii Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Providencia spp. Serratia marcescensEnterobacteriaceae*:
Clinical &	Acinetobacter baumanii-
	Test Device	Predicate Device
ChallengePerformanceData	calcoaceticus complex	EA = 95.8%
	EA = 97.7%CA = 98.4%	CA = 99.3%*Excluding P.mirabilis

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Reproducibility	Best-case: 99.5%Worst-case: 99.5%	Best-case: 99.6%Worst-case: 99.6%
Quality Control	Results within expected range> 95% of the time.	Results within expected range> 95% of the time.
Meets GuidanceDocumentPerformanceRequirements	Yes	Yes
Differencies
Name	ETEST®Sulbactam/Durlobactam (SUD)(0.004/4-64/4 µg/mL)	ETEST® Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) (K183031)
AntimicrobialAgent	Sulbactam/Durlobactam	Meropenem/Vaborbactam
Claimed species	Acinetobacter baumanii-calcoaceticus complex	Enterobacter cloacae complex species Escherichia coli Klebsiella pneumoniae
Product scale	(0.004/4-64/4 µg/mL)	(0.004/8-64/8 µg/mL)

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G. Performance Overview

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 ug/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 330 . (March 2023).

This Premarket Notification (510[k]) presents data in support of ETEST® Sulbactam (SUD) (0.004/4-64/4 us/mL) for Acinetobacter baumanii-calcoaceticus complex.

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® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 ug/mL) by comparing with the CLSI broth microdilution reference method.

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 ug/mL) demonstrated acceptable performance as presented in Table 1 below:

	Strains(N)	% EssentialAgreement(EA)a)	% CategoryAgreement(CA)
Acinetobacter baumanii-calcoaceticus complex	562	97.7%	98.4%

Table 1: Performance Characteristics for ETEST® Sulbactam/Durlobactam

Notes:

EA = % of MIC values within ± 1 dilution of the reference method. a)

In the ETEST® Sulbactam/Durlobactam clinical studies, swabs were used for plate b) 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.

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Limitation:

Due to the occurrence of a Very Major Error with Sulbactam (1/43 resistant isolates), isolates of Acinetobacter baumannii-calcoaceticus complex that provide an MIC of 4 µg/mL should be retested by an alternate method, if critical to patient care.

Reproducibility and Quality Control demonstrated acceptable results.

Conclusion:

The performance data presented in this submission support a substantial equivalence decision. ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 ug/mL) is substantially equivalent to ETEST® Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) (K183031).

Regulation Number and Section

§ 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).