(58 days)
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
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.
The document describes the performance of the ETEST Eravacycline (ERV) (0.002-32 ug/mL) device for determining the minimum inhibitory concentration (MIC) of Eravacycline against various microorganisms.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for Antimicrobial Susceptibility Test (AST) Systems are typically defined by regulatory guidance documents, such as the FDA Class II Special Controls Guidance Document and CLSI standards. For this device, the performance is evaluated based on Essential Agreement (EA) and Category Agreement (CA) with a reference method. While explicit numerical acceptance criteria for EA and CA are not directly stated as pass/fail thresholds in the provided text, the document implies that the reported percentages of EA and CA demonstrate "acceptable performance" and "substantially equivalent performance" when compared to the CLSI reference method and predicate device.
| Performance Metric | Acceptance Criteria (Implied by FDA & CLSI Guidelines) | Reported Device Performance (ETEST® Eravacycline) |
|---|---|---|
| Essential Agreement (EA) | High percentage (typically >90-95%) | Enterobacteriaceae: 99.4% E. faecalis and E. faecium: 100% |
| Category Agreement (CA) | High percentage (typically >90-95%) | Enterobacteriaceae: 98.0% E. faecalis and E. faecium: 94.9% |
| Reproducibility | High percentage (typically >95%) | Best-case: 99.3%, Worst-case: 99.3% |
| Quality Control | Results within range >95% of the times tested | Results within range >95% of the times tested |
| Overall Very Major Error Rate (Enterobacteriaceae) | < 1.5% (adjusted) | 1.1% (adjusted for clinical and challenge isolates) |
| Overall Major and Very Major Error Rates (Enterococcus spp.) | < 3% (adjusted) | 0.0% (adjusted for clinical and challenge isolates) |
2. Sample Size Used for the Test Set and Data Provenance
The test set included both contemporary and stock clinical isolates, as well as challenge strains.
- Enterobacteriaceae (Total N = 552):
- C. freundii (70 isolates)
- C. koseri (30 isolates)
- E. cloacae (72 isolates)
- E. coli (191 isolates)
- K. aerogenes (32 isolates)
- K. oxytoca (43 isolates)
- K. pneumoniae (104 isolates)
- The overall categorical very major error rate for Eravacycline was evaluated on 92 Enterobacteriaceae clinical and challenge isolates for non-susceptible results. This suggests that at least 92 isolates were non-susceptible for this specific analysis.
- Enterococci (Total N = 137):
- E. faecalis (74 isolates)
- E. faecium (63 isolates)
- The overall categorical major and very major error rates for Eravacycline were evaluated on 128 isolates (for major errors) and 9 isolates (for very major errors). This implies at least 128 isolates were included for major error evaluation and 9 for very major error evaluation for non-susceptible isolates.
Data Provenance: The document states that "External evaluations were conducted with contemporary and stock clinical isolates, as well as a set of challenge strains." The country of origin of the data is not specified in the provided text, but bioMérieux SA is based in France.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
The document does not explicitly state the number of experts or their specific qualifications. However, it indicates that the device's performance was compared against the "CLSI M07-A11 January 2018 broth microdilution reference method" and "CLSI M100-S28 January 2018 specifications." This implies that the ground truth was established by laboratory personnel proficient in performing and interpreting these standard reference methods, which are widely accepted in microbiology for antimicrobial susceptibility testing.
4. Adjudication Method for the Test Set
The document does not mention an explicit adjudication method (e.g., 2+1, 3+1, none) for the test set. The ground truth was established by comparison to the CLSI broth microdilution reference method. Any discrepancies or "errors" (e.g., Major Errors, Very Major Errors) are noted, and for some cases (e.g., Klebsiella pneumoniae VME), it mentions that "When tests were repeated in triplicate, all the results were in category agreement," which could be considered a form of internal re-evaluation or confirmation rather than formal adjudication by independent experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The device is a diagnostic test for antimicrobial susceptibility, not an AI-assisted diagnostic tool that directly influences human reader performance.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was conducted. The ETEST® Eravacycline device itself is the "algorithm" in this context, as it's a physical strip with a predefined antibiotic gradient designed to produce a measurable MIC value. Its performance (Essential Agreement, Category Agreement, Reproducibility, Quality Control) was assessed independently by comparing its results directly to the CLSI broth microdilution reference method. No human-in-the-loop interaction for interpretation beyond reading the MIC from the strip itself is implied as part of the evaluated "device performance."
7. Type of Ground Truth Used
The ground truth used was the CLSI M07-A11 January 2018 broth microdilution reference method. This is considered the gold standard for determining minimum inhibitory concentrations (MICs) in microbiology and serves as the primary comparative method for new AST devices. Interpretive categories (susceptible, intermediate, resistant) are typically derived from MIC values based on breakpoints established by CLSI guidelines (e.g., CLSI M100-S28).
8. Sample Size for the Training Set
The document does not provide information about a separate "training set" or its sample size. This type of device (an ETEST strip) is a physical, pre-calibrated product based on a chemical gradient, not a machine learning algorithm that requires a training set in the conventional sense. Its design and manufacturing process would be informed by decades of antimicrobial susceptibility testing principles and prior ETEST product development, rather than a data-driven training phase as seen with AI/ML models.
9. How the Ground Truth for the Training Set Was Established
As no training set is described for this type of device, this question is not applicable. The device's fundamental principle is based on established scientific principles of antibiotic diffusion and bacterial growth inhibition, rather than being "trained" on data.
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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
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- 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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Image /page/3/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle divided into two sections. The top half of the circle is blue and contains the word "BIOMÉRIEUX" in white, sans-serif font. The bottom half of the circle is a gradient of yellow and green.
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 866.1640Manual Antimicrobial Susceptibility Test SystemsProduct 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 fordetermination of antimicrobialsusceptibility of non-fastidiousGram-negative and Gram-positive aerobic bacteria andfastidious bacteria. The systemcomprises a predefinedantibiotic gradient which isused to determine the MinimumInhibitory Concentration (MIC, | Etest® is a quantitativetechnique for determination ofantimicrobial susceptibility ofboth non-fastidious Gram-negative and Gram-positiveaerobic bacteria such asEnterobacteriaceae ,Pseudomonas , Staphylococcus ,and Enterococcus species andfastidious bacteria, such asanaerobes , N. gonorrhoeae , S . |
| antimicrobial agents againstmicroorganisms tested on agarmedia after overnightincubation.Eravacycline has been shown tobe active against most isolatesof the microorganisms listedbelow according to the FDAlabel for this antimicrobialagent | Haemophilus species. Thesystem comprises a predefinedantibiotic gradient which isused to determine the MinimumInhibitory Concentration(MIC), in µg/mL, of differentantimicrobial agents againstmicroorganisms as tested onagar media using overnightincubation. | |
| ETEST® ERV can be used todetermine the MIC ofEravacycline against thefollowing microorganisms: | Telavancin has been shown tobe active against the Gram-positive aerobicmicroorganisms listed belowaccording to the FDA label forthis antimicrobial agent. | |
| Active both in vitro and inclinical infections: | Active both in vitro and inclinical infections: | |
| • Gram-negative:Citrobacter freundii,Enterobacter cloacae,Escherichia coli,Klebsiella oxytoca,Klebsiella pneumoniae.• Gram-positive:Enterococcus faecalis,Enterococcus faecium. | Staphylococcus aureus(including methicillin resistantisolates) | |
| In vitro data are available forthe followingmicroorganisms, but clinicalsignificance is unknown: | ||
| • Citrobacter koseri• Klebsiella aerogenes | ||
| Clinical &ChallengePerformance Data | Enterobacteriaceae: | Staphylococcus aureus: |
| EA = 99.4%CA = 98.0% | EA = 98.4%CA = 97.9% | |
| Enterococcus faecalis andEnterococcus faeciumEA= 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% ofthe times tested. | Results within range > 95% ofthe times tested. |
| Meets GuidanceDocumentPerformanceRequirements | Yes | Yes |
| Differences | ||
| AntimicrobialAgent | 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 resistantisolates) |
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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/0 description: The image contains the logo for bioMérieux. The logo consists of a dark blue semi-circle above the company name, which is written in a bold, sans-serif font. The company name is also in dark blue, matching the color of the semi-circle above it.
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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Image /page/9/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.
(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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Image /page/10/Picture/0 description: The image shows the logo for bioMérieux, a company specializing in in-vitro diagnostics. The logo is a circle divided into two sections. The top half of the circle is dark blue and contains the company name "BIOMÉRIEUX" in white, sans-serif font. The bottom half of the circle is a gradient of yellow and green.
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).
§ 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).