Who is the manufacturer of VITEK 2 AST-Gram Negative Meropenem ( =16 µg/mL)?

bioMerieux, Inc. filed the 510(k) submission for VITEK 2 AST-Gram Negative Meropenem ( =16 µg/mL) (K201675).

What is the FDA product code for VITEK 2 AST-Gram Negative Meropenem ( =16 µg/mL)?

LON. It is classified under 21 CFR 866.1645 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for VITEK 2 AST-Gram Negative Meropenem ( =16 µg/mL)?

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

What are the predicate devices for VITEK 2 AST-Gram Negative Meropenem ( =16 µg/mL)?

VITEK® 2 AST-GN Eravacycline (K191766).

Who can help prepare an FDA 510(k) submission like VITEK 2 AST-Gram Negative Meropenem ( =16 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.

VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)

K201675 · bioMerieux, Inc. · LON · Jul 9, 2021 · Microbiology

Device Facts

Record ID	K201675
Device Name	VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
Applicant	bioMerieux, Inc.
Product Code	LON · Microbiology
Decision Date	Jul 9, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.1645
Device Class	Class 2

Intended Use

VITEK® 2 AST-Gram Negative Meropenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Meropenem in is a quantitative test. Meropenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa In vitro data are available, but clinical significance is unknown: Citrobacter freundii Citrobacter koseri Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Morganella morganii Serratia marcescens The VITEK® 2 Gram Negative Susceptibility Card Meropenem also reports susceptibility for the following additional organisms as listed on the FDA Susceptibility Test Interpretive Criteria website: Acinetobacter spp. 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.

Device Story

VITEK 2 AST-Gram Negative Meropenem card; miniaturized, automated microdilution MIC test. Input: bacterial/yeast isolate diluted in 0.45-0.5% saline. Operation: card contains 64 wells with premeasured antibiotic concentrations and culture media; VITEK 2 system automatically fills, seals, and incubates; monitors growth in each well over time. Output: MIC value and interpretive category result. Used in clinical laboratories by technicians/microbiologists. Output assists clinicians in selecting appropriate antimicrobial therapy for patients with Gram-negative infections.

Clinical Evidence

Bench testing only. External evaluation conducted with 1070 clinical isolates (fresh and stock) and challenge strains. Performance compared to CLSI broth microdilution reference method. Overall performance: 95.0% Essential Agreement (EA) and 95.0% Categorical Agreement (CA). Specific results: Enterobacterales (94.4% EA, 97.0% CA), P. aeruginosa (94.7% EA, 89.7% CA), and Acinetobacter spp. (96.8% EA, 96.3% CA). Very Major Error (VME) rates were 0.0% across all groups.

Technological Characteristics

Automated growth-based detection; optical scanner measures light attenuation (transmittance) every 15 minutes. 64-well AST cards containing nutrient media and premeasured meropenem. Inoculum standardized via DensiCHEK Plus (0.5 McFarland). System software (v9.02) performs analysis. Standalone system. Sterilization: not specified.

Indications for Use

Indicated for antimicrobial susceptibility testing of clinically significant aerobic Gram-negative bacilli (including Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Citrobacter spp., Enterobacter cloacae, Hafnia alvei, Klebsiella oxytoca, Morganella morganii, Serratia marcescens, and Acinetobacter spp.) in clinical laboratories using VITEK 2 or VITEK 2 Compact systems.

Regulatory Classification

Identification

A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”

Predicate Devices

VITEK® 2 AST-GN Eravacycline (K191766)

Related Devices

K091899 — VITEK 2 GRAM NEGATIVE MEROPENEM · bioMerieux, Inc. · Aug 14, 2009
K183360 — VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL) · bioMerieux, Inc. · Feb 26, 2019
K211136 — VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) · bioMerieux, Inc. · Jun 14, 2021
K161217 — VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) · bioMerieux, Inc. · Jan 12, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. July 9, 2021 bioMérieux, Inc. Debra Broyles Sr. Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042 # Re: K201675 Trade/Device Name: VITEK 2 AST-Gram Negative Meropenem (≤ 0.25 - ≥ 16 µg/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, LTW, LTT Dated: June 18, 2020 Received: June 19, 2020 Dear Debra Broyles: 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) Device Name Indications for Use (Describe) | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a yellow-green bottom half. The word "BIOMÉRIEUX" is written in white letters in the blue portion of the circle. #### 510(k) SUMMARY B. C. # VITEK® 2 AST-Gram Negative Meropenem (≤0.25 - ≥16 µg/mL) #### 510(k) Submission Information: | Submitter's Name: | bioMérieux, Inc. | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Address: | 595 Anglum Road Hazelwood, MO 63042 | | Contact Person: | Debra Broyles Senior Regulatory Affairs Specialist | | Phone Number: | 314-731-8805 | | Fax Number: | 314-731-8689 | | Date of Preparation: | December 8, 2020 | | Device Name: | | | Formal/Trade Name: | VITEK® 2 AST-Gram Negative Meropenem (≤0.25 - ≥16 $µg/mL$ ) | | Classification Name: | 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Product Code(s): LON, LTW, LTT | | Common Name: | VITEK® 2 AST-GN Meropenem (≤0.25 - ≥16 $µg/mL$ ) | | Predicate Device: | VITEK® 2 AST-GN Eravacycline (≤ 0.12 - ≥ 4 $µg/mL$ ) (K191766) | #### D. Device Description: 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(0). The VITEK @ 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3). {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue semi-circle on top and a yellow-green semi-circle on the bottom. The word "BIOMÉRIEUX" is written in white letters in the center of the blue semi-circle. 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 portions of a specific antibiotic combined with culture media. The bacterial or yeast 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 cvcle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card. VITEK® 2 AST-GN Meropenem (≤0.25 - ≥16 µg/mL) has the following concentrations in the card: 0.5, 1. 2. 4 and 8 ug/mL (equivalent standard method concentration by efficacy in us/mL). # E. Substantial Equivalence Information: The similarities and differences of the VITEK® 2 AST-GN Meropenem (≤0.25 - ≥16 µg/mL) when compared to the predicate device, VITEK® 2 AST-GN Eravacycline ( ≤ 0.12 –> 4 ug/mL), are described in the Table 1 below. | Item | Device: VITEK® 2 AST-Gram Negative Meropenem ( $\leq$ 0.25 - $\geq$ 16 µg/mL) | Predicate: VITEK® 2 AST-GN Eravacycline ( $\leq$ 0.12 - $\geq$ 4 µg/mL) (K191766) | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Similarities | | | Intended Use | VITEK® 2 AST-Gram Negative Meropenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Meropenem in is a quantitative test. Meropenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. | VITEK® 2 AST-Gram Negative Eravacycline is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Eravacycline is a quantitative test. Eravacycline has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. | | Item | Device: VITEK® 2 AST-Gram Negative Meropenem ( $≤0.25 - ≥16$ µg/mL) | Predicate: VITEK® 2 AST-GN Eravacycline ( $≤ 0.12 - ≥ 4$ µg/mL) (K191766) | | Similarities | | | | | Active in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa In vitro data are available, but clinical significance is unknown: Citrobacter freundii Citrobacter koseri Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Morganella morganii Serratia marcescens The VITEK® 2 Gram Negative Susceptibility Card Meropenem also reports susceptibility for the following additional organisms as listed on the FDA Susceptibility Test Interpretive Criteria website: Acinetobacter spp 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. | Active in vitro and in clinical infections: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae In vitro data are available, but clinical significance is unknown: Citrobacter koseri Klebsiella (Enterobacter) aerogenes 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. | | Item | Device: VITEK® 2 AST-Gram Negative Meropenem ( $\leq$ 0.25 - $\geq$ 16 µg/mL) | Predicate: VITEK® 2 AST-GN Eravacycline ( $\leq$ 0.12 - $\geq$ 4 µg/mL) (K191766) | | Similarities | | | | Test Methodology | Automated quantitative antimicrobial susceptibility test for use with the VITEK® 2 and VITEK® 2 Compact Systems to determine the in vitro susceptibility of microorganisms | Same | | Inoculum | Saline suspension of organism | Same | | Test Card | Gram Negative (AST-GN) Susceptibility Card | Same | | Instrument | VITEK® 2 and VITEK® 2 Compact Systems | Same | | Differences | | | | Antimicrobial Agent | Meropenem | Eravacycline | | Concentrations | 0.5, 2, 6, 12 | 0.25, 1, 2, 4 | # Table 1: Substantial Equivalence {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with the top half being dark blue and the bottom half being a gradient from yellow to green. The word "BIOMÉRIEUX" is written in white letters in the center of the blue portion of the circle. {6}------------------------------------------------ Image /page/6/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 word "BIOMÉRIEUX" in white letters. The bottom half is green and yellow. # F. Intended Use: VITEK® 2 AST-Gram Negative Meropenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Meropenem in is a quantitative test. Meropenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. # Active in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa # In vitro data are available, but clinical significance is unknown: Citrobacter freundii Citrobacter koseri {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a green bottom half. The word "BIOMÉRIEUX" is written in white letters in the blue portion of the circle. Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Morganella morganii Serratia marcescens The VITEK® 2 Gram Negative Susceptibility Card Meropenem also reports susceptibility for the following additional organisms as listed on the FDA Susceptibility Test Interpretive Criteria website: Acinetobacter spp. 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. # G. Performance Overview and Conclusion: VITEK® 2 AST-GN Meropenem 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 Meropenem. 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 Meropenem 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. The VITEK® 2 AST-GN Meropenem demonstrated acceptable performance as presented in Table 2 below: {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with the top half being dark blue and the bottom half being yellow-green. The word "BIOMÉRIEUX" is written in white letters in the center of the blue portion of the circle. | Table 2: VITEK® 2 AST-GN Meropenem Performance | | | | | | | | | |----------------------------------------------------------|---------------------|-----|-----|-----|---------------------|----------------|----------------|------------------| | | %EA | VME | ME | mE | %CA | VME | ME | mE | | Overall Performance (with the reference method) | (1016/1070) 95.0 | N/A | N/A | N/A | (1016/1070) 95.0 | (0/346) 0.0 | (4/680) 0.6 | (50/1070) 4.7 | | Enterobacterales | (537/569) 94.4 | N/A | N/A | N/A | (552/569) 97.0 | (0/65) 0.0 | (4/491) 0.8 | (13/569) 2.3 | | P. aeruginosa | (267/282) 94.7 | N/A | N/A | N/A | (253/282) 89.7 | (0/121) 0.0 | (0/137) 0.0 | (29/282) 10.3 | | Acinetobacter spp. | (212/219) 96.8 | N/A | N/A | N/A | (211/219) 96.3 | (0/160) 0.0 | (0/52) 0.0 | (8/219) 3.7 | Reproducibility and Quality Control demonstrated acceptable results. #### H. References: - 1. MacLowry, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic Sensitivity Testing in the Clinical laboratory, Journal of Laboratory Clinical Medicine, 72:685-687, 1968. - 2. Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. Current 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.