VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. April 14, 2022 bioMerieux, Inc Kyle Olney Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042 Re: K214023 Trade/Device Name: VITEK 2 AST-Gram Negative Ciprofloxacin (<0.06 - >4 ug/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, LTT, LTW Dated: December 21, 2021 Received: December 22, 2021 Dear Kyle Olney: 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). 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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) K214023 Device Name VITEK 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 ug/mL) #### Indications for Use (Describe) VITEK® 2 AST-Gram Negative Ciprofloxacin (≤ 0.06 -> 4 ug/mL) is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Ciprofloxacin is a quantitative test. Ciprofloxacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active both in vitro and in clinical infections Citrobacter Koseri Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Salmonella typhi Serratia marcescens Shigella sonnei In vitro data available but clinical significance is unknown: Enterobacter aerogenes Klebsiella oxytoca Salmonella enteritidis The VITEK® 2 Gram-Negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |----------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. × {3}------------------------------------------------ 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. 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The word "BIOMÉRIEUX" is written in white letters across the blue half of the circle. #### VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 µg/mL) Traditional 510(k) Submission #### 510(k) SUMMARY ### VITEK® 2 AST-GN Ciprofloxacin #### 510(k) Submission Information: | Submitter's Name: | bioMérieux, Inc. | |----------------------|----------------------------------------------------| | Address: | 595 Anglum Road<br>Hazelwood, MO 63042 | | Contact Person: | Kyle J. Olney<br>Regulatory Affairs Specialist | | Phone Number: | 314-731-8666 | | Fax Number: | 314-731-8689 | | Date of Preparation: | December 21, 2021 | | Device Name: | | | Formal/Trade Name: | VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -><br>µg/mL) | | Classification Name: | 21 CFR 866.1645 | | Product Codes: | LON, LTT, and LTW | | Common Name: | VITEK® 2 AST-GN Ciprofloxacin | | Predicate Device: | VITEK® 2 GN Eravacycline (K191766) | #### D. 510(k) Summary: B. C. The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh(1) and Gerlach(2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3).Ciprofloxacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle that is split into two halves. The top half is 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. #### VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 ug/mL) Traditional 510(k) Submission Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured poltions of a specific antibiotic combined with culture media. The isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a repo1t is generated that contains the MIC value along with the interpretive categoly result for each antibiotic contained on the card. ### E. Substantial Equivalence Information: VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 µg/mL) is substantially equivalent to VITEK® 2 GN Eravacycline (K191766). A summary of the similarities VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 µg/mL) and VITEK® 2 GN Eravacycline (K191766). are provided in Table 1 below: | New Device and<br>Predicate Device: | Device:<br>VITEK® 2 AST-GN Ciprofloxacin (0.06->4 µg/mL) | Predicate:<br>VITEK® 2 AST-GN Eravacycline (K191766) | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General Device Characteristic Similarities | | | | Intended<br>Use/Indications for<br>Use | VITEK® 2 AST-Gram Negative<br>Ciprofloxacin is designed for antimicrobial<br>susceptibility testing of Gram negative<br>bacilli and is intended for use with the<br>VITEK® 2 and VITEK® 2 Compact<br>Systems as a laboratory aid in the<br>determination of in vitro susceptibility to<br>antimicrobial agents. VITEK® 2 AST-<br>Gram Negative Ciprofloxacin is a<br>quantitative test.<br><br>The VITEK® 2 Gram-Negative<br>Susceptibility Card is intended for use with<br>the VITEK® 2 Systems in clinical<br>laboratories as an in vitro test to determine<br>the susceptibility of clinically significant<br>aerobic Gram-negative bacilli to<br>antimicrobial agents when used as<br>instructed. | VITEK® 2 AST-Gram Negative Eravacycline is<br>designed for antimicrobial susceptibility testing of<br>Gram negative bacilli and is intended for use with<br>the VITEK® 2 and VITEK® 2 Compact Systems<br>as a laboratory aid in the determination of in vitro<br>susceptibility to antimicrobial agents. VITEK® 2<br>AST-Gram Negative Eravacycline is a<br>quantitative test.<br><br>The VITEK® 2 Gram-Negative Susceptibility Card<br>is intended for use with the VITEK® 2 Systems in<br>clinical laboratories as an in vitro test to determine<br>the susceptibility of clinically significant aerobic<br>Gram-negative bacilli to antimicrobial agents when<br>used as instructed. | | New Device and<br>Predicate Device: | Device:<br>VITEK® 2 AST-GN Ciprofloxacin (0.06 $≥$ 4<br>µg/mL) | Predicate:<br>VITEK® 2 AST-GN Eravacycline (K191766) | | | General Device Characteristic Similarities | | | Test Methodology | Automated quantitative antimicrobial<br>susceptibility test for use with the VITEK® 2 and<br>VITEK® 2 Compact Systems to determine the <i>in vitro</i> susceptibility of Gram negative bacilli | Same | | Inoculum | Saline suspension of organism | Same | | Test Card | VITEK®2 Gram Negative Susceptibility Test Card | Same | | Instrument | VITEK®2 and VITEK®2 Compact Systems | Same | | Analysis Algorithms | Growth Pattern Analysis | Same | | Differences | | | | Antimicrobial<br>Agent | Ciprofloxacin | Eravacycline | | Antimicrobial<br>Concentrations | 0.06, 0.12, 0.5, 1 | 0.25, 1, 2, 4 | | Indications for<br>Use | Ciprofloxacin has been shown to be active against<br>most strains of the microorganisms listed below,<br>according to the FDA label for this antimicrobial.<br><br>Active both <i>in vitro</i> and in clinical infections:<br>Citrobacter koseri<br>Citrobacter freundii<br>Enterobacter cloacae<br>Escherichia coli<br>Klebsiella pneumoniae<br>Morganella morganii<br>Proteus mirabilis<br>Proteus vulgaris<br>Providencia rettgeri<br>Providencia stuartii<br>Pseudomonas aeruginosa<br>Salmonella typhi<br>Serratia marcescens<br>Shigella sonnei<br><br><i>In vitro</i> data available but clinical significance is<br>unknown:<br>Klebsiella (Enterobacter) aerogenes | Eravacycline has been shown to be active against<br>most strains of the microorganisms listed below,<br>according to the FDA label for this antimicrobial.<br><br>Active <i>in vitro</i> and in clinical infections:<br>Citrobacter freundii<br>Enterobacter cloacae<br>Escherichia coli<br>Klebsiella oxytoca<br>Klebsiella pneumoniae<br><br><i>In vitro</i> data are available, but clinical significance is<br>unknown:<br>Citrobacter koseri<br>Klebsiella (Enterobacter) aerogenes) | ### Table 1: Substantial Equivalence {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a green and yellow bottom half. The word "BIOMÉRIEUX" is written in white letters in the center of the blue half of the circle. # VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 – ≥ 4 µg/mL) Traditional 510(k) Submission {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle on top of a yellow and green circle. The word "BIOMÉRIEUX" is written in white letters in the center of the blue circle. #### VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 ug/mL) Traditional 510(k) Submission | <i>Klebsiella oxytoca</i> | | |-------------------------------|--| | <i>Salmonella enteritidis</i> | | #### F. Intended Use: The VITEK® 2 Gram-Negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. The antimicrobial presented in VITEK® 2 AST-GN Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology. The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. Ciprofloxacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active both in vitro and in clinical infections: Citrobacter koseri Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a circle divided into two sections. The top section is a dark blue color and contains the company name "BIOMÉRIEUX" in white, sans-serif font. The bottom section is a gradient of yellow and green. Salmonella typhi Serratia marcescens Shigella sonnei In vitro data available but clinical significance is unknown: Klebsiella aerogenes Klebsiella oxytoca Salmonella enteritidis # G. Performance Overview and Conclusion: To update the VITEK 2 Gram Negative Ciprofloxacin device labeling to include updated FDArecognized breakpoints for Enterobacterales (excludes Salmonella) and Pseudomonas aeruginosa as published in the FDA STIC website. Breakpoints for Salmonella, as well as the FDA indications for use remain unchanged. Previously obtained QC and reproducibility data is applicable to this reevaluation. VITEK® 2 AST-GN Ciprofloxacin (< 0.06 - >4 ug/mL) demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009). The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GN Ciprofloxacin. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GN Ciprofloxacin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. - VITEK® 2 AST-GN Ciprofloxacin demonstrated acceptable performance of 97.2% overall Essential Agreement and 95.5% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results. The VITEK® 2 AST-GN Ciprofloxacin (≤0.06 ->4 µg/mL) demonstrated acceptable performance as presented in Table 2 below: {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a circle divided into two sections. The top section is a dark blue color and contains the company name "BIOMÉRIEUX" in white, sans-serif font. The bottom section is a gradient of yellow and green. ### VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 ug/mL) Traditional 510(k) Submission 100 #### Table 2: VITEK® 2 AST-GN Ciprofloxacin Performance Essential Agreement Category Agreement % Reproducibility % % Error Antimicrobial Antibiotic Bp1 Comment2 Antimicrobial Code Version % EA VME ME mE % CA VME ME mE CIP cip02n CLSI #, E (FDA)* Enterobacteriaceae 97.9 N/A N/A 95.2 4.6 N/A 0.4 0.1 (excluding Salmonella) #, E Ciprofloxacin 93.6 N/A N/A N/A 96.6 0.0 3.4 0.0 Pseudomonas aeruginosa #, E 100.0 0.0 N/A N/A N/A 100.0 0.0 0.0 Salmonella * VITEK® 2 Systems Ciprofloxacin MIC values for Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, Providencia stuartii, Pseudomonas aeruginosa and Salmonella species tended to be in exact ageement or at least one doubling dilution higher than the reference method. *For specific information regarding susceptive criteria and associated test methods and quality controls standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC. Kev: # = US Food and Drug Administration 510(k) cleared E = External performance data Quality Control demonstrated acceptable results. #### H. References - 1. MacLowly, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic Sensitivity Testing in the Clinical laborato1y, Journal ofLaborato1y Clinical Medicine, 72:685-687, 1968. - 2. Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. CU1Tent Techniques for Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL,1974. - 3. Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, Philadelphia, PA, 1976.