(57 days)
Not Found
No
The description details a manual, quantitative technique using a physical strip with a predefined antibiotic gradient. The MIC is determined by visually reading the intersection of the inhibition ellipse with the scale on the strip. There is no mention of automated analysis, image processing, or any computational methods that would suggest the use of AI or ML.
No
The device is used for determining the antimicrobial susceptibility of bacteria to specific drugs, which is a diagnostic purpose, not a therapeutic one. It provides information to guide treatment, but does not directly treat a condition.
Yes
The ETEST® system is used to determine the Minimum Inhibitory Concentration (MIC) of antimicrobial agents against microorganisms, which is a diagnostic technique for assessing bacterial susceptibility to antibiotics.
No
The device description explicitly states that ETEST® is a "thin, inert and non-porous plastic strip" carrying an antibiotic gradient. This is a physical component, not software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria." This is a diagnostic test performed in vitro (outside the body) on biological samples (bacterial cultures) to provide information about a patient's condition (susceptibility to antibiotics).
- Device Description: The description details a product used to perform this in vitro test.
- Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution reference method," which is a standard in vitro diagnostic technique. The metrics evaluated (% Essential Agreement, % Category Agreement) are relevant to the performance of an in vitro diagnostic test.
The core function of the device is to analyze a biological sample (bacterial growth on agar) in vitro to provide diagnostic information (antimicrobial susceptibility). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
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. 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/Durlobactam against the following microorganisms:
• Acinetobacter baumannii-calcoaceticus complex
Product codes (comma separated list FDA assigned to the subject device)
JWY
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.
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® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 ug/mL) by comparing with the CLSI broth microdilution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Strains (N): 562
% Essential Agreement (EA): 97.7%
% Category Agreement (CA): 98.4%
Notes:
EA = % of MIC values within ± 1 dilution of the reference method.
In the ETEST® Sulbactam/Durlobactam 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 reproducibility: Best-case: 99.5%, Worst-case: 99.5%
Quality Control: Results within expected range > 95% of the time.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA): 97.7%
Category Agreement (CA): 98.4%
Reproducibility: Best-case: 99.5%, Worst-case: 99.5%
Quality Control: Results within expected range > 95% of the time.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
Not Found
§ 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).
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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
1
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
2
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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Image /page/3/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle at the top, with the company name "BIOMÉRIEUX" in white, sans-serif font. Below the company name, the circle transitions into a gradient of yellow and green.
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 866.1640 |
| Manual Antimicrobial Susceptibility Test Systems | |
| Product 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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Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with the top half in dark blue and the bottom half in a gradient of yellow to green. The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue portion of the circle.
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.
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.
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 the | ||
| determination of antimicrobial | ||
| susceptibility of non-fastidious | ||
| Gram-negative and | ||
| Gram-positive aerobic bacteria | ||
| and fastidious bacteria. Thesystem 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. | 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. | ||
| Sulbactam/Durlobactam has | ||
| been shown to be active against | ||
| the aerobic microorganisms | ||
| listed below according to the | Meropenem/Vaborbactam has | |
| been shown to be active against | ||
| the Gram-negative aerobic | ||
| microorganisms 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 marcescens | ||
| Enterobacteriaceae*: | ||
| Clinical & | Acinetobacter baumanii- | |
| Test Device | Predicate Device | |
| Challenge | ||
| Performance | ||
| Data | calcoaceticus complex | EA = 95.8% |
| EA = 97.7% | ||
| CA = 98.4% | CA = 99.3% | |
| *Excluding P.mirabilis |
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Image /page/6/Picture/1 description: The image is a semi-circle shape that is yellow on the left side and green on the right side. The colors blend together in the middle, creating a gradient effect. The semi-circle is positioned horizontally, with the flat side at the top and the curved side at the bottom. The background is white.
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Image /page/7/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue semi-circle at the top, with the word "BIOMÉRIEUX" in white, sans-serif font inside the semi-circle. Below the blue semi-circle is a yellow and green gradient that forms a semi-circle shape.
| 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 Guidance
Document
Performance
Requirements | 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) |
| Antimicrobial
Agent | 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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Image /page/8/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a gradient bottom half that transitions from yellow to green. The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue portion of the circle.
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) | % Essential
Agreement
(EA)a) | % Category
Agreement
(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).