Who is the manufacturer of VITEK 2 AST-Gram Positive Linezolid ( =8 µg/mL)?

Biomérieux, Inc. filed the 510(k) submission for VITEK 2 AST-Gram Positive Linezolid ( =8 µg/mL) (K212849).

What is the FDA product code for VITEK 2 AST-Gram Positive Linezolid ( =8 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 Positive Linezolid ( =8 µg/mL)?

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

Who can help prepare an FDA 510(k) submission like VITEK 2 AST-Gram Positive Linezolid ( =8 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 Positive Linezolid (<=0.5 >=8 µg/mL)

Q: What are the predicate devices for VITEK 2 AST-Gram Positive Linezolid ( =8 µg/mL)?

VITEK 2 AST-GP Linezolid (K032766).

K212849 · Biomérieux, Inc. · LON · Feb 4, 2022 · Microbiology

Device Facts

Record ID	K212849
Device Name	VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)
Applicant	Biomérieux, Inc.
Product Code	LON · Microbiology
Decision Date	Feb 4, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 866.1645
Device Class	Class 2

Intended Use

VITEK® 2 AST-Gram Positive Linezolid is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive Linezolid is a quantitative test. Linezolid 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: Enterococcus faecium (vancomycin-resistant isolates only) Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus agalactiae In vitro data are available, but clinical significance is unknown: Enterococcus faecalis (including vancomycin-resistant isolates) Enterococcus faecium (vancomycin-susceptible isolates) Staphylococcus epidermidis (including methicillin-resistant isolates) Staphylococcus haemolyticus The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.

Device Story

VITEK 2 AST-Gram Positive Linezolid is an in vitro diagnostic test for determining antimicrobial susceptibility of gram-positive bacteria. The device uses VITEK 2 or VITEK 2 Compact instruments to perform automated dilution of antimicrobial agents. Input consists of bacterial isolates prepared as direct colony suspensions. The system measures growth inhibition to determine Minimum Inhibitory Concentration (MIC) values. Results are provided to clinicians to guide antibiotic therapy selection. The modification involves reanalysis of MIC results for Staphylococcus spp. using updated FDA-recognized interpretative criteria. The device is used in clinical microbiology laboratories by trained technicians. The output assists in identifying resistant strains and informing clinical decision-making for linezolid treatment.

Clinical Evidence

Performance evaluated using clinical and challenge isolates compared to CLSI agar dilution reference method. Results: Enterococcus spp. (EA 99.8%, CA 98.0%), Staphylococcus spp. (EA 97.2%, CA 99.7%), S. agalactiae (EA 100%, CA 100%). Staphylococcus haemolyticus subset showed EA 82.9% and CA 97.1% with one major error. Reproducibility was 100%.

Technological Characteristics

Microdilution-based 64-well card; contains premeasured linezolid (0.5, 1, 2 ug/mL) and culture media. Automated incubation and optical growth monitoring. Compatible with VITEK 2 and VITEK 2 Compact systems. Uses Discriminant Analysis algorithm.

Indications for Use

Indicated for antimicrobial susceptibility testing of Staphylococcus spp., Enterococcus spp., and Streptococcus agalactiae to linezolid in clinical settings 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-GP Linezolid (K032766)

Related Devices

K032766 — VITEK 2 GRAM POSITIVE LINEZOLID · bioMerieux, Inc. · Oct 31, 2003
K111599 — VITEK 2 AST-ST LINEZOLID · bioMerieux, Inc. · Aug 12, 2011
K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) · bioMerieux, Inc. · Mar 11, 2024

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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 4, 2022 bioMérieux, Inc Esther Hernandez Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042 Re: K212849 Trade/Device Name: VITEK 2 AST-Gram Positive Linezolid (<0.5 ->8 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 Dated: September 8, 2021 Received: September 9, 2021 Dear Esther Hernandez: 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 {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., D(ABMM), F(AAM) Branch Chief 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, a French multinational biotechnology company. The logo consists of a blue circle on top and a yellow-green gradient circle on the bottom. The word "BIOMÉRIEUX" is written in white letters inside the blue circle. VITEK® 2 AST-GP Linezolid Special 510(k) Submission ## 510(k) SUMMARY ## VITEK® 2 AST-GP Linezolid ### A. 510(k) Submission Information: | Submitter's Name: | bioMérieux, Inc. | |----------------------|---------------------------------------------------------------------------------------------------------------------------| | Address: | 595 Anglum Road Hazelwood, MO 63042 | | Contact Person: | Esther Hernandez Regulatory Affairs Specialist | | Phone Number: | 314-731-8841 | | Fax Number: | 314-731-8689 | | Date of Preparation: | September 03, 2021 | | Device Name: | | | Formal/Trade Name: | VITEK® 2 AST- Gram Positive Linezolid (≤ 0.5 -> 8 µg/mL) | | Classification Name: | 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Product Code LON | | Common Name: | VITEK® 2 AST-GP Linezolid | | Predicate Device: | VITEK® 2 AST-GP Linezolid (K032766) | ## D. Device Description: 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). 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 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a blue semi-circle at the top with the company name "BIOMÉRIEUX" in white text. Below the blue semi-circle is a yellow-green semi-circle, creating a circular shape overall. 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 cycle, 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-GP Linezolid has the following concentrations in the card: 0.5, 1, and 2 ug/mL (equivalent standard method concentration by efficacy in us/mL). ## E. Substantial Equivalence Information The similarities and differences of the VITEK 2 AST-GP Linezolid when compared to the predicate device. VITEK 2 AST-GP Linezolid (K032766), are described in the following table. The only difference between both devices is the change in breakpoints for Staphylococcus species. | Device and Predicate Device(s): | Device: K212849 | Predicate Device: K032766 | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Trade Name | VITEK 2 AST-GP Linezolid | VITEK 2 AST-GP Linezolid | | General Device Characteristic Similarities | | | | Intended Use/Indications for Use | VITEK® 2 AST-Gram Positive Linezolid is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive Linezolid is a quantitative test. Linezolid has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. | Intended use(s): The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp. , Enterococcus spp. , Streptococcus agalactiae , and S. pneumoniae . The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 System in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp. , Enterococcus spp. , and S. agalactiae to antimicrobial agents when used as | | | Active in vitro and in clinical infections: Enterococcus faecium (vancomycin- resistant isolates only) Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus agalactiae | instructed in the Online Product Information. Indication(s) for use: The indication will include the testing of linezolid at concentrations of 0.5, 1, and 2 for a calling range of < 0.5 -> 8 µg/ml on the VITEK 2 Gram Positive Susceptibility Card. | | | In vitro data are available, but clinical significance is unknown: Enterococcus faecalis (including vancomycin-resistant isolates) Enterococcus faecium (vancomycin- susceptible isolates) Staphylococcus epidermidis (including methicillin-resistant isolates) Staphylococcus haemolyticus | | | | The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed. | | | 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 | | Antimicrobial Agent | Linezolid | Same | | Inoculum | Saline suspension of organism | Same | | Test Card | Gram-positive (AST-GP) Susceptibility Card | Same | | Analysis Algorithms | Discriminant Analysis | Same | | Instrument | VITEK® 2 and VITEK® 2 Compact Systems | Same | | Concentrations | 0.5, 1, 2 | Same | | General Device Characteristic Differences | | | | Staphylococcus spp. | S ≤ 4, I -, R >8 µg/mL | Susceptible-only category | ### Table1: Substantial Equivalence {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 semi-circle at the top with the company name "BIOMÉRIEUX" in white text. Below the blue semi-circle is a semi-circle that transitions from yellow to green. ## VITEK® 2 AST-GP Linezolid Special 510(k) Submission {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle on top of a yellow-green circle. The word "BIOMÉRIEUX" is written in white letters inside the blue circle. VITEK® 2 AST-GP Linezolid Special 510(k) Submission | Breakpoints | S < 4 ug/mL | |-------------|-------------| ## F. Intended Use: VITEK® 2 AST-Gram Positive Linezolid is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive Linezolid is a quantitative test. Linezolid 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: Enterococcus faecium (vancomycin-resistant isolates only) Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus agalactiae In vitro data are available, but clinical significance is unknown: Enterococcus faecalis (including vancomycin-resistant isolates) Enterococcus faecium (vancomycin-susceptible isolates) Staphylococcus epidermidis (including methicillin-resistant isolates) Staphylococcus haemolyticus The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed. ## G. Performance Overview and Conclusion: VITEK® 2 AST-GP Linezolid demonstrated substantially equivalent performance when compared with the Agar dilution 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). {7}------------------------------------------------ The Premarket Notification (Special 510[k]) presents data in support of VITEK® 2 AST- GP Linezolid. 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-GP Linezolid by comparing its performance with the CLSI agar dilution reference method incubated at 16-20 hours (20-24 hours for Streptococcus agalactiae). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GP Linezolid (≤0.5 ->8 µg/mL) demonstrated acceptable performance as presented in Table 2 below: | Antimicrobial | Comment | Essential Agreement | | | | Category Agreement | | | | % Reproducibility | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|---------------------|-----|-----|-----|--------------------|----------------|-----------------|-----------------|----------------------| | | | %Error | | | | % Error | | | | | | | | %EA | VME | ME | mE | %CA | VME | ME | mE | | | Linezolid | #, E Enterococcus spp. | (402/403) 99.8% | N/A | N/A | N/A | (395/403) 98.0% | (0/8) 0.0% | (0/389) 0.0% | (8/403) 2.0% | | | | #, E Staphylococcus spp. | (379/390) 97.2% | N/A | N/A | N/A | (389/390) 99.7% | (0/11) 0.0% | (1/379) 0.3% | (0/390) 0.0% | 100% | | | #, E Streptococcus agalactiae | (64/64) 100% | N/A | N/A | N/A | (64/64) 100% | (0/0) 0.0% | (0/64) 0.0% | (0/64) 0.0% | | | VITEK 2 AST-Gram Positive Linezolid MIC values tended to be in exact agreement or at least one doubling dilution higher when testing Staphylococcus haemolyticus compared to the CLSI reference agar dilution method. When evaluating performance of the clinical and challenge isolates, testing with Staphylococcus haemolyticus isolates yielded an EA of 82.9% (29/35) and an CA of 97.1% (34/35). There was one major error (2.9%%, 1/35). | | | | | | | | | | | Table 2: VITEK® 2 AST-GP Linezolid Performance Key # = US Food and Drug Administration 510(k) cleared E = External performance data Quality Control demonstrated acceptable results. #### 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. {8}------------------------------------------------

VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)

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VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)