Who is the manufacturer of ETEST Eravacycline (ERV) (0.002 32 µg/mL)?

Biomerieux S.A. filed the 510(k) submission for ETEST Eravacycline (ERV) (0.002 32 µg/mL) (K192050).

What is the FDA product code for ETEST Eravacycline (ERV) (0.002 32 µg/mL)?

JWY. It is classified under 21 CFR 866.1640 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for ETEST Eravacycline (ERV) (0.002 32 µg/mL)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ETEST Eravacycline (ERV) (0.002 32 µg/mL)?

ETEST® Telavancin (TLA) (0.002-32 ug/mL) (K180936).

Who can help prepare an FDA 510(k) submission like ETEST Eravacycline (ERV) (0.002 32 µg/mL)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ETEST Eravacycline (ERV) (0.002 32 µg/mL)

K192050 · Biomerieux S.A. · JWY · Sep 27, 2019 · Microbiology

Device Facts

Record ID	K192050
Device Name	ETEST Eravacycline (ERV) (0.002 32 µg/mL)
Applicant	Biomerieux S.A.
Product Code	JWY · Microbiology
Decision Date	Sep 27, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.1640
Device Class	Class 2

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 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

Device Story

ETEST® is a manual, quantitative antimicrobial susceptibility test. It consists of a thin, inert, non-porous plastic strip with a predefined antibiotic gradient on one side and an MIC reading scale on the other. The strip is applied to an inoculated agar surface; the antibiotic gradient transfers into the agar, forming a stable, continuous, exponential concentration gradient. Following overnight incubation, a symmetrical inhibition ellipse forms around the strip. The MIC value is determined by reading the concentration on the scale where the ellipse intersects the strip. Used in clinical laboratories by trained personnel. Results assist healthcare providers in selecting appropriate antimicrobial therapy for patients with bacterial infections.

Clinical Evidence

Performance evaluated using 600 clinical and 79 challenge isolates (542 Enterobacteriaceae, 137 Enterococcus spp.). Compared to CLSI broth microdilution (BMD) reference method. Overall performance: Enterobacteriaceae (99.4% EA, 98.0% CA); Enterococcus spp. (100% EA, 94.9% CA). Adjusted very major error rate for Enterobacteriaceae was 1.1%; adjusted major/very major error rate for Enterococcus spp. was 0%. Trending toward higher MIC values observed for C. freundii, E. coli, and K. aerogenes.

Technological Characteristics

Thin, inert, non-porous plastic strip with predefined antibiotic gradient and MIC reading scale. Manual application to inoculated agar media. Overnight incubation required. No energy source. Standalone device.

Indications for Use

Indicated for determination of antimicrobial susceptibility of non-fastidious Gram-negative (Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae) and Gram-positive (Enterococcus faecalis, Enterococcus faecium) aerobic bacteria, plus in vitro data for Citrobacter koseri and Klebsiella aerogenes. For prescription use.

Regulatory Classification

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.

Predicate Devices

ETEST® Telavancin (TLA) (0.002-32 ug/mL) (K180936)

Related Devices

K190154 — ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) · Biomerieux S.A. · May 1, 2019
K192738 — ETEST Delafloxacin (DFX) (0.002-32 µg/mL) · Biomerieux S.A. · Nov 26, 2019
K180936 — ETEST Telavancin (TLA) (0.002-32 ug/mL) · Biomerieux S.A. · Jul 3, 2018
K170670 — Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) · bioMerieux, Inc. · May 31, 2017
K052366 — ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA · Ab Biodisk · Oct 13, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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. The logo is simple and professional, and it is easily recognizable. 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}------------------------------------------------ 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K192050 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) | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | <table><tr><td>☒ Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td>□ Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | ☒ 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) | | | #### 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 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 866.1640 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) | {4}------------------------------------------------ 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 {5}------------------------------------------------ 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) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | {6}------------------------------------------------ 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ 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% {9}------------------------------------------------ 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). {10}------------------------------------------------ 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).

ETEST Eravacycline (ERV) (0.002 32 µg/mL)

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ETEST Eravacycline (ERV) (0.002  32 µg/mL)

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ETEST Eravacycline (ERV) (0.002 32 µg/mL)