VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin

Q: Who is the manufacturer of VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin?

bioMerieux, Inc. filed the 510(k) submission for VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin (K220803).

Q: What is the FDA product code for VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin?

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

Q: What is the regulatory pathway for VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin?

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

Q: Does VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin use AI or machine learning?

Yes. VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin (K220803) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Q: What are the predicate devices for VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin?

Vitek 2 Gram Positive Moxifloxacin (K032399).

Q: Who can help prepare an FDA 510(k) submission like VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin?

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.

Q: Can an AI/ML device like VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

K220803 · bioMerieux, Inc. · LON · Jan 27, 2023 · Microbiology

Device Facts

Record ID	K220803
Device Name	VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin
Applicant	bioMerieux, Inc.
Product Code	LON · Microbiology
Decision Date	Jan 27, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.1645
Device Class	Class 2
Attributes	AI/ML

Intended Use

VITEK® 2 AST-Gram Positive Moxifloxacin 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 Moxifloxacin is a quantitative test. Moxifloxacin 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: Enterococcus faecalis Staphylococcus aureus In vitro data are available, but their clinical significance is unknown: Staphylococcus epidermidis 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-GP Moxifloxacin is an in vitro diagnostic test for determining antimicrobial susceptibility of Gram-positive bacteria. The device uses a miniaturized, automated microdilution broth technique. Clinical laboratory technicians prepare a saline suspension of the patient isolate, which is used to rehydrate antimicrobial-containing wells in a test card. The VITEK 2 system automatically fills, seals, and incubates the card, monitoring bacterial growth via optical sensors over a defined period. The system's algorithm performs discriminant analysis on growth data to calculate the Minimum Inhibitory Concentration (MIC) and determine the interpretive category (susceptible, intermediate, or resistant). Results are reported to the clinician to guide antibiotic therapy selection. The device provides quantitative susceptibility data, aiding in the management of infections caused by organisms like Enterococcus faecalis and Staphylococcus aureus.

Clinical Evidence

Performance evaluated via external study using fresh and stock clinical isolates and challenge strains. Compared against CLSI agar dilution reference method. Results: Enterococcus faecalis (n=154) showed 98.7% essential agreement (EA) and 99.4% category agreement (CA); Staphylococcus spp. (n=331) showed 94.9% EA and 99.4% CA. No major errors (ME) or very major errors (VME) reported for E. faecalis; Staphylococcus spp. showed 0.7% ME and 0.0% VME.

Technological Characteristics

Automated microdilution antimicrobial susceptibility test card. Contains 64 wells with premeasured antibiotic concentrations (0.25, 2, 8 µg/mL) and culture media. Sensing principle: optical growth monitoring. Connectivity: VITEK 2 and VITEK 2 Compact instrument platforms. Software algorithm: Discriminant Analysis.

Indications for Use

Indicated for antimicrobial susceptibility testing of Gram-positive microorganisms (Staphylococcus spp., Enterococcus spp., and S. agalactiae) 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 Gram Positive Moxifloxacin (K032399)

Related Devices

K032399 — VITEK 2 GRAM POSITIVE MOXIFLOXACIN · bioMerieux, Inc. · Sep 10, 2003
K132573 — VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN · bioMerieux, Inc. · Sep 13, 2013
K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) · bioMerieux, Inc. · Mar 11, 2024
K202396 — VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) · bioMerieux, Inc. · Sep 14, 2021

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. January 27, 2023 bioMerieux, Inc Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042 #### Re: K220803 Trade/Device Name: VITEK 2 AST-Gram Positive Moxifloxacin (≤0.25 - ≥ 8 µg/ml), VITEK 2 AST-GP Moxifloxacin (≤ 0.25 - ≥ 8 µg/mL), VITEK 2 AST-GP Moxifloxacin 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: March 17, 2022 Received: March 18, 2022 #### Dear Cherece Jones: 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 -S 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) K220803 Device Name VITEK® 2 AST-GP Moxifloxacin (<0.25 - >8 ug/mL) #### Indications for Use (Describe) VITEK® 2 AST-Gram Positive Moxifloxacin 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 Moxifloxacin is a quantitative test. Moxifloxacin 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: Enterococcus faecalis Staphylococcus aureus In vitro data are available, but their clinical significance is unknown: Staphylococcus epidermidis 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. Type of Use (Select one or both, as applicable) | <svg height="12" width="12"> <polygon points="1 1, 11 1, 11 11, 1 11" style="fill:none;stroke:black;stroke-width:1"></polygon> <polygon points="2 2, 10 2, 10 10, 2 10" style="fill:none;stroke:black;stroke-width:1"></polygon> <line style="stroke:black;stroke-width:1" x1="2" x2="10" y1="2" y2="10"></line> <line style="stroke:black;stroke-width:1" x1="10" x2="2" y1="2" y2="10"></line> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <svg height="12" width="12"> <polygon points="1 1, 11 1, 11 11, 1 11" style="fill:none;stroke:black;stroke-width:1"></polygon> </svg> 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 green bottom half. The word "BIOMÉRIEUX" is written in white letters in the center of the blue half of the circle. # 510(k) SUMMARY # VITEK® 2 AST Gram-Positive Moxifloxacin (≤0.25 - ≥8 µg/mL) #### A. 510(k) Submission Information: | Submitter's Name: | bioMérieux, Inc. | |----------------------|-------------------------------------------------------------------------------------------------------| | Address: | 595 Anglum Road Hazelwood, MO 63042 | | Contact Person: | Cherece L. Jones Staff Regulatory Affairs Specialist | | Phone Number: | 314-731-8684 | | Fax Number: | 314-731-8689 | | Date of Preparation: | March 16, 2022 | | Device Name: | | | Formal/Trade Name: | VITEK® 2 AST Gram-Positive Moxifloxacin (≤0.25 - ≥8 µg/mL) | | Classification Name: | 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System | | Product Code(s): | LON, LTT, LTW | | Common Name: | VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) | | Predicate Device: | VITEK® 2 AST- GP Moxifloxacin (≤0.25 - ≥8 µg/mL) (K032399) | # 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(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 the top half being dark blue and the bottom half being yellow-green. The company name, BIOMÉRIEUX, is written in white, sans-serif font in the center of the blue portion of the 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 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. #### E. Substantial Equivalence Information: VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) is substantially equivalent to VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) (K032399). A summary of the similarities and differences of the VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) and VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) (K032399) are provided in Table 1 below: | Table 1: Substantial Equivalence | | | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | New Device and Predicate Device: | New Device: VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) | Predicate Device: VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) (K032399) | | General Device Characteristic Similarities | | | | Intended Use/Indications for Use | VITEK® 2 AST-Gram Positive Moxifloxacin 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 Moxifloxacin is a quantitative test. Moxifloxacin 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: Enterococcus faecalis | VITEK 2® Gram Positive Moxifloxacin is designed for antimicrobial susceptibility testing of Staphylococcus aureus (methicillin- susceptible strains only). It is intended for use with the VITEK 2® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. 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 instructed in the Online Product | # Table 1: Substantial Equivalonco {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 of the circle is dark blue, and the bottom half is light green. The company name, "BIOMÉRIEUX", is written in white, sans-serif font in the center of the blue half of the circle. | New Device and Predicate Device: | New Device: VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) | Predicate Device: VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) (K032399) | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | General Device Characteristic Similarities | | | | | Staphylococcus aureus | Information. | | | In vitro data are available, but their clinical significance is unknown: Staphylococcus epidermidis | | | | 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 | Moxifloxacin | Same | | Concentrations | 0.25, 2, and 8 | 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 | | General Device Characteristic Differences | | | | Breakpoints | Enterococcus faecalis S ≤ 1, I 2, ≥ 4R Staphylococcus spp. S ≤ 0.5, I 1, ≥ 2R | Staphylococcus spp. S ≤ 2, I 4, ≥ 8R | #### F. Intended Use: VITEK® 2 AST-Gram Positive Moxifloxacin 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 Moxifloxacin is a quantitative test. {6}------------------------------------------------ Image /page/6/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 text "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue portion of the circle. Moxifloxacin 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: Enterococcus faecalis Staphylococcus aureus In vitro data are available, but their clinical significance is unknown: Staphylococcus epidermidis 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 Moxifloxacin (≤0.25 - ≥8 ug/mL) demonstrated substantially equivalent performance when compared with the CLSI 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). The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GP Moxifloxacin. 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 AST-GP Moxifloxacin by comparing its performance with the CLSI agar dilution reference method incubated at 16-20 hours. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. The VITEK® 2 AST-GP Moxifloxacin (≤0.25 - ≥8 µg/mL) demonstrated acceptable performance as presented in Table 2 below: {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle with a blue upper half and a yellow-green lower half. The company name, "BIOMÉRIEUX", is written in white, sans-serif capital letters in the center of the blue portion of the circle. #### Essential Agreement Catego Antimicrob Category Agreement Antimicrob Code Reprodu al cibility % Error % Error %EA VME ME %CA VME ME mE mE (mxf02n) FDA Moxifloxacir MXF #, E (CLSI) (152/154) (153/154) (0/43) (0/110) (1/154) N/A N/A Enterococcus N/A 98.7 99.4 0.0 0.0 0.6 faecalis 100.0 #. E (329/331) (314/331) (1/152) (0/163) (16/331) Staphylococcus N/A N/A N/A 94.9 4.8 99.4 0.7 0.0 spp The VITEK 2 AST-GP Moxifloxacin MIC values tended to be in exact agreement or at least one doubling dilution higher when testing Enterococcus faecalis and Staphylococcus aureus compared to the CLSI reference agar dilution method. #### Key: #= US Food and Drug Administration 510(k) cleared E = External performance data #### Quality Control demonstrated acceptable results. ● | Table 3: CLSI® Quality Control Organisms VITEK® 2 Results | | | | | | | |-----------------------------------------------------------|--------|----------------------------------------------------------|----------------------------------------------------------|--|--|--| | Antimicrobic | Code | E. faecalis ATCC® 29212™ | S. aureus ATCC® 29213™ | | | | | Moxifloxacin | mxf02n | ≤ 0.25 - 0.5⁰ (FDA/CLSI QC range is 0.06 – 0.5) | ≤ 0.25⁰ (FDA/CLSI QC range is 0.03- 0.12 ug/mL) | | | | Numerical values are expressed in µg/mL. ^ Does not include the full CLSI/FDA-recommended dilution range for QC testing with this organism. #### 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. #### TTEK® 2 AST-GP Moxifloxacin Performance {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle with a blue upper half and a yellow-green lower half. The company name, "BIOMÉRIEUX", is written in white, sans-serif font in the center of the blue portion of the circle. - 3. Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, Philadelphia, PA, 1976.