(58 days)
Not Found
No
The device description outlines a manual method for determining antimicrobial susceptibility based on visual interpretation of bacterial growth inhibition along a predefined antibiotic gradient. 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 to determine antimicrobial susceptibility and Minimal Inhibitory Concentration (MIC) for diagnostic purposes, not for direct treatment of patients.
Yes
The ETEST® determines the Minibitory Concentration (MIC) of antimicrobial agents against microorganisms, which is a diagnostic measurement to guide treatment decisions for bacterial infections.
No
The device description explicitly states it is a "thin, inert and non-porous plastic strip" carrying an antibiotic gradient, which is a physical hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to determine the antimicrobial susceptibility of bacteria, which is a test performed on biological samples (bacteria grown on agar media) in vitro (outside of the body). This information is used to guide treatment decisions.
- Device Description: The device is a strip with an antibiotic gradient designed to interact with the inoculated agar and the growing bacteria to produce a measurable result (the MIC). This is a diagnostic tool used in a laboratory setting.
- Performance Studies: The performance studies compare the device's results to a reference method (CLSI broth microdilution), which is a standard practice for evaluating the accuracy of diagnostic tests.
- Predicate Device: The predicate device listed (ETEST® Telavancin) is also an ETEST product used for antimicrobial susceptibility testing, further indicating that this type of device falls under the IVD category.
The core function of the ETEST® is to provide diagnostic information about the susceptibility of microorganisms 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 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 Minibitory Concentration (MC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media using overnight incubation.
Eravacycline has been shown to be active against most isolates of the microorganisms listed below according to this antimicrobial agent.
ETEST® ERV can be used to determine the MIC of Eravacycline against the following microorganisms:
Active both in vitro and in clinical infections:
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
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 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® Eravacycline contains a range of eravacycline from 0.002 to 32 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
Prescription Use (Part 21 CFR 801 Subpart D)
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 contemporary and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of ETEST® Eravacycline (ERV) (0.002-32 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)
ETEST® Eravacycline (ERV) (0.002-32 ug/mL) 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.
This Premarket Notification (510(k)) presents data in support of ETEST® Eravacycline (ERV) (0.002-32 ug/mL) for: Enterobacteriaceae, Enterococcus faecalis and Enterococcus facium. External evaluations were conducted with contemporary and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of ETEST® Eravacycline (ERV) (0.002-32 µg/mL) by comparing with the CLSI broth microdilution reference method.
ETEST® Eravacycline (ERV) (0.002-32 µg/mL) demonstrated acceptable performance as presented in Table 1 below:
Table 1: Performance Characteristics for ETEST® Eravacycline
| % Essential Agreement (EA) | % Category Agreement (CA) | |
|---|---|---|
| Enterobacteriaceae | 99.4 | 98.0 |
| E. faecalis and E. faecium | 100 | 94.9 |
Reproducibility and Quality Control demonstrated acceptable results.
Notes:
- a) EA = % of MIC values within ± 1 dilution of the reference method.
- b) The performance data presented for Enterobacteriaceae include C. freundii (70), C. koseri (30), E. cloacae (72), E. coli (191), K. aerogenes (32), K. oxytoca (43) and K. pneumoniae (104).
- c) The performance data presented for enterococci include E. faecalis (74) and E. faecium (63).
- d) When testing Klebsiella pneumoniae isolates, one VME was not within essential agreement of the reference method. The adjusted VME rate for this species is 2.9% (1/34). When tests were repeated in triplicate, all the results were in category agreement.
- e) ETEST® Eravacycline MIC values tended to be in exact agreement or at least one doubling dilution higher when testing C. freundii, E. coli and K. aerogenes compared to the CLSI reference broth microdilution method. Of these species, only C. freundii reported categorical errors (7.0% (4/57) were major errors), all of which were within essential agreement of the reference method.
- f) The overall categorical very major error rate for Eravacycline when testing Enterobacteriaceae clinical and challenge isolates is 5.4% (5/92). Based on the essential agreement and lack of an intermediate breakpoint for Eravacycline, the overall adjusted very major error rate for Enterobacteriaceae clinical and challenge isolates is 1.1% (1/92).
- g) The overall categorical major and very major error rates for Eravacycline when testing Enterococcus spp. (E. faecalis and E. faecium) clinical and challenge isolates are 3.1% (4/128) and 33.3% (3/9), respectively. Based on the essential agreement and lack of an intermediate breakpoint for Eravacycline, the overall adjusted major and very major error rates for testing Enterococcus spp. clinical and challenge isolates are 0.0% (0/128 and 0/9).
- h) The optional inoculator and ETEST® strip applicator were used for plate inoculation and applying ETEST® strips onto agar media. In the ETEST® Eravacycline clinical studies, swabs were used for plate inoculation/streaking and forceps were used for ETEST® strip application.
Limitations
- The ability of ETEST® Eravacycline to detect the following non-susceptible Enterobacteriaceae isolates is unknown because non-susceptible isolates were not available at the time of comparative testing: Citrobacter koseri.
- Due to the lack of an intermediate interpretive category for Eravacycline, results obtained with E. cloacae, K. pneumoniae and E. faecium showed potential for very major errors compared to the reference method and results obtained with E. faecalis showed potential for major and very major errors. If critical to patient care, testing should be repeated using an alternative testing/reference method prior to reporting results for:
- E. cloacae when ETEST MIC is 0.5 µg/mL (Susceptible)
- K. pneumoniae when ETEST MIC is 0.25 or 0.5 µg/mL (Susceptible)
- E. faecium when ETEST MIC is 0.064 ug/mL (Susceptible)
- E. faecalis when ETEST MIC is 0.064 (Susceptible) or 0.125 ug/mL (non-Susceptible).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA), Category Agreement (CA), Very Major Error Rate (VME), Major Error Rate
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
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September 27, 2019
bioMerieux SA Marine Taravant Regulatory Affairs Specialist 376 Chemin de l'Orme Marcy-l'Etoile, 69280 Fr
Re: K192050
Trade/Device Name: ETEST Eravacycline (ERV) (0.002 - 32 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: July 30, 2019 Received: July 31, 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/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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
ETEST® Eravacycline (ERV) (0.002-32 µq/mL)
Indications for Use (Describe)
ETEST® is a manual, quantitative technique for 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 Minibitory Concentration (MC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media using overnight incubation.
Eravacycline has been shown to be active against most isolates of the microorganisms listed below according to this antimicrobial agent.
ETEST® ERV can be used to determine the MIC of Eravacycline against the following microorganisms:
Active both in vitro and in clinical infections:
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
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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ETEST® Eravacycline (ERV) (0.002-32 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 |
| Regulatory Affairs Specialist | |
| Phone Number: | +33 (0)4 78 87 21 26 |
| Date of Preparation: | July 30th, 2019 |
B. Device Name:
| Formal/Trade Name: | ETEST® Eravacycline (ERV)
(0.002 – 32 µg/mL) |
|----------------------|------------------------------------------------------------------------------------------|
| Classification Name: | 21 CFR 866.1640
Manual Antimicrobial Susceptibility Test Systems
Product Code: JWY |
| Common Name(s): | ETEST® Eravacycline; ETEST® ERV |
| C. Predicate Device: | ETEST® Telavancin (TLA)
(0.002-32 µg/mL) (K180936) |
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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 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® Eravacycline contains a range of eravacycline from 0.002 to 32 µg/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.
Eravacycline has been shown to be active against most isolates of the microorganisms listed below according to the FDA label for this antimicrobial agent.
ETEST® ERV can be used to determine the MIC of Eravacycline against the following microorganisms:
Active both in vitro and in clinical infections:
Gram-negative:
Citrobacter freundii Enterobacter cloacae Escherichia coli
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Image /page/5/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a blue circle at the top and a yellow-green circle at the bottom, separated by a white horizontal bar. The company name, "BIOMÉRIEUX", is written in white, sans-serif font across the white bar, positioned between the two circles.
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
F. Summary of the technological characteristics of the new device in comparison to those or the predicate device
The similarities and differences of the ETEST® Eravacycline (ERV) (0.002-32 µg/mL) when compared to the predicate device, ETEST® Telavancin (TLA) (0.002-32 µg/mL) (K180936), are described in the table below.
| Test Device | Predicate Device | |
|---|---|---|
| Similarities | ||
| ETEST® Eravacycline (ERV) | ETEST® Telavancin | |
| (0.002-32 µg/mL) | (0.002-32 µg/mL) | |
| 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, | Etest® is a quantitative | |
| technique for determination of | ||
| antimicrobial susceptibility of | ||
| both non-fastidious Gram- | ||
| negative and Gram-positive | ||
| aerobic bacteria such as | ||
| Enterobacteriaceae , | ||
| Pseudomonas , Staphylococcus , | ||
| and Enterococcus species and | ||
| fastidious bacteria, such as | ||
| anaerobes , N. gonorrhoeae , S . | ||
| antimicrobial agents against | ||
| microorganisms tested on agar | ||
| media after overnight | ||
| incubation. | ||
| Eravacycline has been shown to | ||
| be active against most isolates | ||
| of the microorganisms listed | ||
| below according to the FDA | ||
| label for this antimicrobial | ||
| agent | Haemophilus species. 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 as tested on | ||
| agar media using overnight | ||
| incubation. | ||
| ETEST® ERV can be used to | ||
| determine the MIC of | ||
| Eravacycline against the | ||
| following microorganisms: | Telavancin has been shown to | |
| be active against the Gram- | ||
| positive aerobic | ||
| microorganisms listed below | ||
| according to the FDA label for | ||
| this antimicrobial agent. | ||
| Active both in vitro and in | ||
| clinical infections: | Active both in vitro and in | |
| clinical infections: | ||
| • Gram-negative: | ||
| Citrobacter freundii, | ||
| Enterobacter cloacae, | ||
| Escherichia coli, | ||
| Klebsiella oxytoca, | ||
| Klebsiella pneumoniae. | ||
| • Gram-positive: | ||
| Enterococcus faecalis, | ||
| Enterococcus faecium. | Staphylococcus aureus | |
| (including methicillin resistant | ||
| isolates) | ||
| In vitro data are available for | ||
| the following | ||
| microorganisms, but clinical | ||
| significance is unknown: | ||
| • Citrobacter koseri | ||
| • Klebsiella aerogenes | ||
| Clinical & | ||
| Challenge | ||
| Performance Data | Enterobacteriaceae: | Staphylococcus aureus: |
| EA = 99.4% | ||
| CA = 98.0% | EA = 98.4% | |
| CA = 97.9% | ||
| Enterococcus faecalis and | ||
| Enterococcus faecium | ||
| EA= 100% | ||
| CA= 94.9% | ||
| Reproducibility | Best-case: 99.3% | |
| Worst-case: 99.3% | Best-case: 100% | |
| Worst-case: 100% | ||
| 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 | Eravacycline | Telavancin |
| Claimed species | Citrobacter freundii , | |
| Enterobacter cloacae , | ||
| Escherichia coli , | ||
| Klebsiella oxytoca , | ||
| Klebsiella pneumoniae , | ||
| Enterococcus faecalis , | ||
| Enterococcus faecium , | ||
| Citrobacter koseri , | ||
| Klebsiella aerogenes | Staphylococcus aureus | |
| (including methicillin resistant | ||
| isolates) | ||
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Image /page/6/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue semi-circle at the top, with the company name "BIOMÉRIEUX" in white, sans-serif font inside the semi-circle. Below the blue semi-circle is a yellow and green gradient shape.
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Image /page/7/Picture/1 description: The image shows a semi-circle shape that transitions from yellow to green. The left side of the semi-circle is a bright yellow color, which gradually fades into a vibrant green on the right side. The semi-circle is positioned against a white background, which makes the colors stand out.
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Image /page/8/Picture/0 description: The image is a logo for BIOMÉRIEUX. The logo is a circle divided 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.
G. Performance Overview
ETEST® Eravacycline (ERV) (0.002-32 ug/mL) 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.
This Premarket Notification (510(k)) presents data in support of ETEST® Eravacycline (ERV) (0.002-32 ug/mL) for: Enterobacteriaceae, Enterococcus faecalis and Enterococcus facium. External evaluations were conducted with contemporary and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of ETEST® Eravacycline (ERV) (0.002-32 µg/mL) by comparing with the CLSI broth microdilution reference method.
ETEST® Eravacycline (ERV) (0.002-32 µg/mL) demonstrated acceptable performance as presented in Table 1 below:
| % Essential Agreement | % Category Agreement | |
|---|---|---|
| (EA) | (CA) | |
| Enterobacteriaceae b),d),e),f),h) | 99.4 | 98.0 |
| E. faecalis and E. faecium c),g),h) | 100 | 94.9 |
Table 1: Performance Characteristics for ETEST® Eravacycline
Reproducibility and Quality Control demonstrated acceptable results.
Notes:
- a) EA = % of MIC values within ± 1 dilution of the reference method.
- b) The performance data presented for Enterobacteriaceae include C. freundii (70), ● C. koseri (30), E. cloacae (72), E. coli (191), K. aerogenes (32), K. oxytoca (43) and K. pneumoniae (104).
- c) The performance data presented for enterococci include E. faecalis (74) and E. ● faecium (63).
- . d) When testing Klebsiella pneumoniae isolates, one VME was not within essential agreement of the reference method. The adjusted VME rate for this species is 2.9%
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(1/34). When tests were repeated in triplicate, all the results were in category agreement.
- e) ETEST® Eravacycline MIC values tended to be in exact agreement or at least one doubling dilution higher when testing C. freundii, E. coli and K. aerogenes compared to the CLSI reference broth microdilution method. Of these species, only C. freundii reported categorical errors (7.0% (4/57) were major errors), all of which were within essential agreement of the reference method.
- f) The overall categorical very major error rate for Eravacycline when testing . Enterobacteriaceae clinical and challenge isolates is 5.4% (5/92). Based on the essential agreement and lack of an intermediate breakpoint for Eravacycline, the overall adjusted very major error rate for Enterobacteriaceae clinical and challenge isolates is 1.1% (1/92).
- g) The overall categorical major and very major error rates for Eravacycline when . testing Enterococcus spp. (E. faecalis and E. faecium) clinical and challenge isolates are 3.1% (4/128) and 33.3% (3/9), respectively. Based on the essential agreement and lack of an intermediate breakpoint for Eravacycline, the overall adjusted major and very major error rates for testing Enterococcus spp. clinical and challenge isolates are 0.0% (0/128 and 0/9).
- h) The optional inoculator and ETEST® strip applicator were used for plate . inoculation and applying ETEST® strips onto agar media. In the ETEST® Eravacycline clinical studies, swabs were used for plate inoculation/streaking and forceps were used for ETEST® strip application.
Limitations
- The ability of ETEST® Eravacycline to detect the following non-susceptible ● Enterobacteriaceae isolates is unknown because non-susceptible isolates were not available at the time of comparative testing: Citrobacter koseri.
- Due to the lack of an intermediate interpretive category for Eravacycline, results obtained ● with E. cloacae, K. pneumoniae and E. faecium showed potential for very major errors compared to the reference method and results obtained with E. faecalis showed potential for major and very major errors. If critical to patient care, testing should be repeated using an alternative testing/reference method prior to reporting results for:
- E. cloacae when ETEST MIC is 0.5 µg/mL (Susceptible)
- K. pneumoniae when ETEST MIC is 0.25 or 0.5 µg/mL (Susceptible)
- E. faecium when ETEST MIC is 0.064 ug/mL (Susceptible)
- E. faecalis when ETEST MIC is 0.064 (Susceptible) or 0.125 ug/mL (non-Susceptible).
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Conclusion:
The performance data presented in this submission support a substantial equivalence decision. ETEST® Eravacycline (ERV) (0.002-32 µg/mL) is substantially equivalent to ETEST® Telavancin (TLA) (0.002-32 µg/mL) (K180936).