(91 days)
CLSI M07-A11 January 2018
No
The device description and performance studies focus on a manual, quantitative technique based on a predefined antibiotic gradient and visual interpretation of bacterial growth inhibition. There is no mention of automated analysis, image processing, or any computational methods that would suggest the use of AI or ML.
No
This device is an in vitro diagnostic (IVD) device used to determine antimicrobial susceptibility, not a device intended to treat or manage a disease or condition in a patient.
Yes
This device is designed to determine the Minimum Inhibitory Concentration (MIC) of antibiotics against microorganisms, which provides information crucial for diagnosing the susceptibility of bacteria to specific antimicrobial agents and guiding treatment decisions.
No
The device description clearly states it is a "thin, inert and non-porous plastic strip" with a predefined antibiotic gradient, indicating it is a physical hardware component used in a laboratory setting.
Yes, this device is an IVD (In Vitro Diagnostic).
The provided text explicitly states the "Intended Use / Indications for Use" as a "manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria." This describes a test performed on biological samples (bacteria) outside of the body to provide information for diagnosis or treatment.
Furthermore, the "Device Description" details how the strip is used with inoculated agar media to determine the Minimum Inhibitory Concentration (MIC) of an antimicrobial agent against microorganisms. This is a classic example of an in vitro diagnostic test used in clinical microbiology laboratories.
The "Summary of Performance Studies" also describes external evaluations comparing the device to a reference method for determining antimicrobial susceptibility, which is a standard practice for validating IVD devices.
N/A
Intended Use / Indications for 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.
Piperacillin/Tazobactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent.
ETEST® P/T can be used to determine the MIC of Piperacillin/Tazobactam against the following microorganisms:
Active both in vitro and in clinical infections: Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa
Product codes
JWY
Device Description
ETEST® is a thin, inert and non-porous plastic strip carrying on one side the MIC reading scale in ug/mL, and on the other side a predefined antibiotic gradient.
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® Piperacillin/Tazobactam contains a range of piperacillin from 0.016 to 256 ug/mL, overlaid with a fixed concentration of 4 ug/mL of tazobactam.
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® Piperacillin/Tazobactam by comparing with the CLSI broth microdilution reference method.
The performance data presented for Enterobacteriaceae include E. coli (168), K. pneumoniae (190), C. koseri (46), M. morganii (41), P. mirabilis (41), P. vulgaris (31), S. marcescens (47), P. stuartii (36), P. rettgeri (28) and S. enterica (31).
Summary of Performance Studies
Study Type: Performance Comparison.
Sample Size: Enterobacteriaceae (638 total isolates), Pseudomonas aeruginosa (unknown), Acinetobacter spp. (unknown).
Standalone Performance:
Enterobacteriaceae: Essential Agreement (EA) 95.8%, Category Agreement (CA) 93.3%
Pseudomonas aeruginosa: Essential Agreement (EA) 98.3%, Category Agreement (CA) 93.3%
Acinetobacter spp.: Essential Agreement (EA) 91.6%, Category Agreement (CA) 89.2%
Key Results: ETEST® Piperacillin/Tazobactam demonstrated substantially equivalent performance when compared with the CLSI M07-A11 January 2018 broth microdilution reference method.
Key Metrics
Essential Agreement (EA) = % of MIC values within ± 1 dilution of the reference method.
Category Agreement (CA)
For Enterobacteriaceae: EA 95.8%, CA 93.3%
For Pseudomonas aeruginosa: EA 98.3%, CA 93.3%
For Acinetobacter spp.: EA 91.6%, CA 89.2%
Categorical errors when testing Klebsiella pneumoniae isolates were mostly due to minor errors (19/190, 10%). Two of 99 resistant isolates gave a very major error.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
May 1, 2019
bioMerieux SA Marine Taravant Regulatory Affairs Specialist 376, chemin de l'Orme Marcy-l'Etoile, 69280 Fr
Re: K190154
Trade/Device Name: ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: January 29, 2019 Received: January 30, 2019
Dear Marine Taravant:
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Image /page/2/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 yellow and green. The company name, "BIOMÉRIEUX", is written in white, sans-serif font in the center of the blue portion of the circle.
ETEST® Piperacillin/Tazobactam
A. 510(k) Submission Information:
| Submitter's Name: | bioMerieux SA |
|---|---|
| Address: | 376 Chemin de l'Orme |
| 69280 Marcy-l'Etoile, FRANCE | |
| Contact Person: | Marine Taravant |
| Regulatory Affairs Specialist | |
| Phone Number: | +33 (0)4 78 87 21 26 |
| Date of Preparation: | January 25th, 2019 |
B. Device Name:
| Formal/Trade Name: | ETEST® Piperacillin/Tazobactam (P/T) |
|---|---|
| (0.016/4 – 256/4 µg/mL) | |
| Classification Name: | 21 CFR 866.1640 |
| Manual Antimicrobial Susceptibility Test Systems | |
| Product Code: JWY | |
| Common Name(s): | ETEST® Piperacillin/Tazobactam; ETEST® P/T |
| C. Predicate Device: | ETEST® Ceftazidime/Avibactam (CZA) |
| (0.016-256 µg/mL) (K172150) |
3
Image /page/3/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a yellow-green gradient bottom half. 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 on one side the MIC reading scale in ug/mL, and on the other side a predefined antibiotic gradient.
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® Piperacillin/Tazobactam contains a range of piperacillin from 0.016 to 256 ug/mL, overlaid with a fixed concentration of 4 ug/mL of tazobactam.
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.
Piperacillin/Tazobactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent.
ETEST® P/T can be used to determine the MIC of Piperacillin/Tazobactam against the following microorganisms:
Active both in vitro and in clinical infections: Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa
4
Image /page/4/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle with the top half in dark blue and the bottom half in a gradient of yellow and green. The word "BIOMÉRIEUX" is written in white in the center of the blue portion of the circle.
In vitro data are available for the following microorganisms, but clinical significance is unknown:
Citrobacter koseri Morganella morganii Proteus mirabilis Proteus vulgaris Serratia marcescens Providencia stuartii Providencia rettgeri Salmonella enterica
F. Performance Overview
ETEST® Piperacillin/Tazobactam demonstrated substantially equivalent performance when compared with the CLSI M07-A11 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-S28 January 2018.
ETEST® This Notification (510[k]) presents data support Premarket Piperacillin/Tazobactam for Gram negative aerobic bacteria: Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter baumannii. 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® Piperacillin/Tazobactam by comparing with the CLSI broth microdilution reference method.
ETEST® Piperacillin/Tazobactam demonstrated acceptable performance as presented in Table 1 below:
| % Essential Agreement | % Category Agreement | |
|---|---|---|
| (EA) a) | (CA) | |
| Enterobacteriaceae b), c), d), e), f) | 95.8 | 93.3 |
| Pseudomonas aeruginosa f) | 98.3 | 93.3 |
| Acinetobacter spp. e), f) | 91.6 | 89.2 |
Table 1: Performance Characteristics for ETEST® Piperacillin/Tazobactam
5
Image /page/5/Picture/0 description: The image is a logo for bioMérieux. The logo is a circle with a blue top half and a yellow-green gradient bottom half. The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue portion of the circle.
Notes:
- a) EA = % of MIC values within ± 1 dilution of the reference method.
- b) The performance data presented for Enterobacteriaceae include E. coli (168), K. pneumoniae (190), C. koseri (46), M. morganii (41), P. mirabilis (41), P. vulgaris (31), S. marcescens (47), P. stuartii (36), P. rettgeri (28) and S. enterica (31).
- c) ETEST® Piperacillin/Tazobactam MIC values tended to be in exact agreement or at least one doubling dilution lower when testing Klebsiella pneumoniae compared to the CLSI reference broth microdilution method.
- d) Categorical errors when testing Klebsiella pneumoniae isolates were mostly due to minor errors (19/190, 10%). Two of 99 resistant isolates gave a very major error. Upon repeat testing, a reference MC value could not be confidently established for one of the isolates due to extensive variability with the reference method.
- e) ETEST® Piperacillin/Tazobactam MIC values tended to be in exact agreement or at least one doubling dilution higher when testing A. baumannii, M. morganii, P. mirabilis, P. rettgeri, P. stuartii and S. marcescens compared to the CLSI reference broth microdilution method.
- () Optional inoculator and ETEST® strip applicator can be used for plate inoculation and applying ETEST® strips onto agar media. In the ETEST® Piperacillin/Tazobactam clinical studies, swabs were used for plate inoculation/streaking and forceps were used for ETEST® strip application.
LIMITATIONS
- · The ability of ETEST® Piperacillin/Tazobactam to detect the following resistant Enterobacteriaceae isolates is unknown because resistant isolates were either not available or an insufficient number was encountered at the time of comparative testing: Proteus mirabilis, Proteus vulgaris and Salmonella enterica.
Reproducibility and Quality Control demonstrated acceptable results.
G. Conclusion:
The performance data presented in this submission support a substantial equivalence decision. ETEST® Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) is substantially equivalent to ETEST® Ceftazidime/Avibactam (CZA) (0.016-256 ug/mL) (K172150).