(242 days)
Not Found
No
The device description and performance studies focus on a manual, quantitative technique using a physical strip with a predefined antibiotic gradient. There is no mention of automated analysis, image processing, or any computational methods that would typically involve AI/ML.
No
The device is used to determine the minimum inhibitory concentration of an antibiotic against microorganisms, which is a diagnostic purpose, not a therapeutic one.
Yes
The device determines the Minimum Inhibitory Concentration (MIC) of antibiotics against microorganisms, which is a diagnostic measure used to guide treatment decisions for bacterial infections.
No
The device description clearly states that ETEST® is a "thin, inert and non-porous plastic strip" which is a physical hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is 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 a biological sample (bacteria).
- Device Description: The description details a device used to measure the Minimum Inhibitory Concentration (MIC) of an antibiotic against microorganisms grown on agar media. This is a standard method for in vitro diagnostic testing in microbiology.
- Performance Studies: The document describes performance studies comparing the device to a reference method (CLSI agar microdilution), which is typical for validating the performance of an IVD.
- Key Metrics: The metrics reported (Essential Agreement and Category Agreement) are standard metrics used to evaluate the performance of antimicrobial susceptibility testing devices, which are a type of IVD.
- Predicate Device: The mention of a predicate device (K192050 ETEST® ERAVACYCLINE) further indicates that this device is being submitted for regulatory review as an IVD, as predicate devices are used for demonstrating substantial equivalence to legally marketed IVDs.
The core function of the device is to provide diagnostic information about the susceptibility of bacteria to an antimicrobial agent, which is a classic example of an in vitro diagnostic test.
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.
Fosfomycin has been shown to be active against the Gram-positive aerobic microorganisms listed below according to the FDA label for this antimicrobial agent.
ETEST® (FO) can be used to determine the MIC of Fosfomycin against the following microorganisms:
Active both in vitro and in clinical infections:
- Escherichia coli
- Enterococcus faecalis
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 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 ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.
ETEST® Fosfomycin contains a range of fosfomycin from 0.032 to 512 ug/mL.
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® Fosfomycin (FO) (0.032-512 ug/mL) by comparing with the CLSI agar microdilution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ETEST® Fosfomycin (FO) (0.032-512 µg/mL) demonstrated substantially equivalent performance when compared with the CLSI M07-A11 January 2018 agar 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 30th Ed. (January 2020).
This Premarket Notification (510[k]) presents data in support of ETEST® Fosfomycin (FO) (0.032-512 ug/mL) for Escherichia coli and Enterococcus faecalis.
Performance Data:
Enterococcus faecalis: Strains (N) = 191; % Essential Agreement (EA) = 97.9; % Category Agreement (CA) = 93.7
Escherichia coli: Strains (N) = 238; % Essential Agreement (EA) = 90.8; % Category Agreement (CA) = 99.2
Reproducibility: Overall reproducibility results > 95%
Quality Control: Results within expected range > 95% of the time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
EA = % of MIC values within ± 1 dilution of the reference method.
Enterococcus faecalis: EA = 97.9%, CA = 93.7%
Escherichia coli: EA= 90.8%, CA= 99.2%
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).
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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 12, 2021
bioMerieux SA Marine Taravant Regulatory Affairs Specialist 376, chemin de l'Orme Marcy-l'Etoile, 69280 France
Re: K210757
Trade/Device Name: ETEST Fosfomycin (FO) (0.032-512 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: March 12, 2021 Received: March 15, 2021
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
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, Ph.D. (ABMM) 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
Indications for Use
510(k) Number (if known)
Device Name ETEST® Fosfomycin (FO) (0.032-512 ug/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 ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation.
Fosfomycin has been shown to be active against the Gram-positive aerobic microorganisms listed below according to the FDA label for this antimicrobial agent.
ETEST® (FO) can be used to determine the MIC of Fosfomycin against the following microorganisms:
Active both in vitro and in clinical infections:
- Escherichia coli
- Enterococcus faecalis
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image is a circular logo for BIOMÉRIEUX. The top half of the circle is a dark blue color, and the bottom half is a gradient of yellow and green. The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue portion of the circle.
ETEST® FOSFOMYCIN (FO) (0.032-512 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: | |
| Marine Taravant | |
| Phone Number: | +33 (0)4 78 87 21 26 |
| Date of Preparation: | March 12th, 2021 |
B. Device Name:
| Formal/Trade Name: | ETEST® FOSFOMYCIN (FO) (0.032–512 µg/mL) |
|---|---|
| Classification Name: | 21 CFR 866.1640 |
| Manual Antimicrobial Susceptibility Test Systems | |
| Product Code: JWY | |
| Common Name(s): | ETEST® FOSFOMYCIN; ETEST® FO |
| C. Predicate Device: | |
| (K192050) | ETEST® ERAVACYCLINE (ERV) (0.002-32 µg/mL) |
4
Image /page/4/Picture/0 description: The image is a logo for the company BIOMÉRIEUX. The logo is a circle with the top half being a solid dark blue color. The bottom half of the circle is a gradient that transitions from yellow to green. The company name, BIOMÉRIEUX, is written in white, uppercase letters 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 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 ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.
ETEST® Fosfomycin contains a range of fosfomycin from 0.032 to 512 ug/mL.
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.
Fosfomycin has been shown to be active against the Gram-positive and Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent.
ETEST® FO can be used to determine the MIC of Fosfomycin against the following microorganisms:
Active both in vitro and in clinical infections:
- -Escherichia coli
- -Enterococcus faecalis
F. Summary of the technological characterictics of the new device in comparison to those of the predicate device.
The similarities and differences of ETEST® Fosfomycin (FO) when compared to the predicate device, ETEST® Eravacycline (ERV) (K192050) are described in the table below:
5
Image /page/5/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with the top half being dark blue and the bottom half being a gradient of yellow to green. The word "BIOMÉRIEUX" is written in white letters across the center of the blue portion of the circle.
| Similarities | ||
|---|---|---|
| Test Device | Predicate Device | |
| ETEST® Fosfomycin (FO) | ||
| (0.032-512 µg/mL) | ETEST® Eravacycline (ERV) | |
| (0.002-32 µg/mL) (K192050) | ||
| 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. | 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. |
| Fosfomycin has been shown to be active against the aerobic microorganisms listed below according to the FDA label for this antimicrobial agent. | Eravacycline has been shown to be active against most isolates of the bacteria listed below according to the FDA label for this antimicrobial agent; | |
| ETEST® FO can be used to determine the MIC of fosfomycin against the | ETEST® ERV can be used to determine the MIC of Eravacycline against the | |
| Test Device | Predicate Device | |
| following microorganisms: |
Active both in vitro and in
clinical infections:
Ο Escherichia coli
Ο Enterococcus faecalis
Clinical &
Challenge
Performance Data | following microorganisms.
Active both in vitro and in
clinical infections:
Aerobes: Gram-negative:
Citrobacter freundii,
Enterobacter cloacae,
Escherichia coli,
Klebsiella oxytoca,
Klebsiella pneumoniae. Gram-positive:
Enterococcus faecalis,
Enterococcus faecium. In vitro data are available for
the following microorganisms,
but clinical significance is
unknown:
Citrobacter koseri Klebsiella aerogenes | |
| Enterococcus faecalis:EA =
97.9%
CA = 93.7%
Escherichia. coli:
EA= 90.8%
CA= 99.2% | Enterobacteriaceae:
EA = 99.4%
CA = 98.0%
Enterococcus faecalis and
Enterococcus faecium
EA= 100%
CA= 94.9% | |
| Reproducibility | Overall reproducibility results > 95% | Overall reproducibility results > 95% |
| 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 | | |
| | ETEST® Fosfomycin (FO)
(0.032-512 µg/mL) | ETEST® Eravacycline (ERV)
(0.002-32 µg/mL) (K192050) |
| Antimicrobial
Agent | Fosfomycin | Eravacycline |
| Product scale | 0.032-512 µg/mL | 0.002-32 µg/mL |
6
Image /page/6/Picture/0 description: The image contains 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 semi-circle is a gradient of yellow and green.
7
Image /page/7/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue upper half and a yellow-green lower half. The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue half of the circle.
G. Performance Overview
ETEST® Fosfomycin (FO) (0.032-512 µg/mL) demonstrated substantially equivalent performance when compared with the CLSI M07-A11 January 2018 agar 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 30th Ed. (January 2020).
This Premarket Notification (510[k]) presents data in support of ETEST® Fosfomycin (FO) (0.032-512 ug/mL) for Escherichia coli and Enterococcus faecalis.
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® Fosfomycin (FO) (0.032-512 ug/mL) by comparing with the CLSI agar microdilution reference method.
8
Image /page/8/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle divided horizontally into two sections. The top section is a dark blue color and contains the word "BIOMÉRIEUX" in white, sans-serif font. The bottom section is a gradient of yellow and green.
ETEST® Fosfomycin (FO) (0.032-512 µg/mL) demonstrated acceptable performance as presented in Table 1 below:
| | Strains
(N) | % Essential
Agreement
(EA)a) | % Category
Agreement
(CA) |
|---------------------------------|----------------|------------------------------------|---------------------------------|
| Enterococcus faecalis b) | 191 | 97.9 | 93.7 |
| Escherichia coli b)c) | 238 | 90.8 | 99.2 |
Table 1: Performance Characteristics for ETEST® Fosfomycin
Notes:
a) EA = % of MIC values within ± 1 dilution of the reference method.
- b) The optional Inoculator RETRO C80™ and Applicator SIMPLEX C76™ can be used to inoculate plates and apply ETEST® strips to agar media. In the ETEST® Fosfomycin clinical studies, swabs were used for plate inoculation/ streaking, and the Vacuum Pen NEMA C88TM were used for ETEST® strip application
- ETEST® Fosfomycin MIC values tended to be in exact agreement or at least one doubling dilution c) lower when testing Escherichia coli compared to the reference agar dilution method.
Reproducibility and Quality Control demonstrated acceptable results.
Conclusion:
The performance data presented in this submission support a substantial equivalence decision. ETEST® Fosfomycin (FO) (0.032-512 ug/mL) is substantially equivalent to ETEST® Eravacycline (ERV) (0.002-32 µg/mL) (K192050).