Who is the manufacturer of VITEK 2 AST-Gram Negative Levofloxacin ( /=8 ug/mL)?

bioMerieux, Inc. filed the 510(k) submission for VITEK 2 AST-Gram Negative Levofloxacin ( /=8 ug/mL) (K222378).

What is the FDA product code for VITEK 2 AST-Gram Negative Levofloxacin ( /=8 ug/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 Levofloxacin ( /=8 ug/mL)?

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

Does VITEK 2 AST-Gram Negative Levofloxacin ( /=8 ug/mL) use AI or machine learning?

Yes. VITEK 2 AST-Gram Negative Levofloxacin ( /=8 ug/mL) (K222378) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like VITEK 2 AST-Gram Negative Levofloxacin ( /=8 ug/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.

Can an AI/ML device like VITEK 2 AST-Gram Negative Levofloxacin ( /=8 ug/mL) 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.

VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)

K222378 · bioMerieux, Inc. · LON · Jun 26, 2023 · Microbiology

Device Facts

Record ID	K222378
Device Name	VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)
Applicant	bioMerieux, Inc.
Product Code	LON · Microbiology
Decision Date	Jun 26, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.1645
Device Class	Class 2
Attributes	AI/ML

Intended Use

VITEK® 2 AST-Gram Negative Levofloxacin 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 Levofloxacin is a quantitative test. Levofloxacin 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: Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens Active in vitro but clinical significance unknown: Citrobacter koseri Citrobacter freundii Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Pantoea agglomerans Proteus vulgaris Providencia rettgeri Providencia stuartii VITEK® 2 AST-Gram Negative Levofloxacin also reports the susceptibility for the following additional organism as listed on the FDA Susceptibility Test Interpretive Criteria website: Salmonella 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 Levofloxacin is an automated, growth-based, quantitative antimicrobial susceptibility test (AST) system. It utilizes miniaturized cards containing 64 micro-wells with premeasured antimicrobial concentrations (0.25–8 μg/mL) and nutrient media. Clinical laboratories use the device to determine the minimum inhibitory concentration (MIC) of Levofloxacin for Gram-negative bacilli. The system operates by diluting bacterial isolates (auto or manual) into the card, which is then incubated and monitored by an optical scanner. The scanner measures light attenuation every 15 minutes to track organism growth. An analysis program processes these growth patterns to calculate MIC values and interpretive categories (S, I, R). Results are automatically reported to the clinician, aiding in the selection of appropriate antimicrobial therapy. The device benefits patients by providing standardized, rapid susceptibility data to guide clinical decision-making for infections caused by susceptible organisms.

Clinical Evidence

Bench testing only. Re-analysis of original clinical and challenge data (346 Enterobacterales, 225 P. aeruginosa) and additional testing for Salmonella spp. (48 isolates). Combined Essential Agreement (EA) and Categorical Agreement (CA) were >90% for all groups. Minor errors observed: 2.0% for Enterobacterales, 5.7% for P. aeruginosa, 2.08% for Salmonella. Major errors: 1.6% for P. aeruginosa. No very major errors reported. Trending analysis identified higher MIC values for E. coli, K. pneumoniae, and P. aeruginosa, and lower MIC values for S. marcescens.

Technological Characteristics

Microdilution MIC technique; 64-well plastic test card; automated incubation/reading; saline-based inoculum; uses Discriminant Analysis algorithm; standalone instrument platform; no specific material standards cited.

Indications for Use

Indicated for antimicrobial susceptibility testing of clinically significant aerobic Gram-negative bacilli, including Enterobacterales, Pseudomonas aeruginosa, and Salmonella spp. Prescription use only.

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-Gram Negative Levofloxacin (K072038)

Related Devices

K072038 — VITEK 2 GRAM NEGATIVE LEVOFLOXACIN · bioMerieux, Inc. · Sep 12, 2007
K191766 — VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) · bioMerieux, Inc. · Aug 5, 2019
K032788 — VITEK 2 GRAM NEGATIVE GATIFLOXACIN · bioMerieux, Inc. · Nov 4, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION". June 26, 2023 bioMerieux, Inc. Esther Hernandez Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042 Re: K222378 Trade/Device Name: VITEK 2 AST-Gram Negative Levofloxacin (<0.125 - >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, LTT, LTW Dated: August 4, 2022 Received: August 5, 2022 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 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 -S Ribhi Shawar, Ph.D. (ABMM) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K222378 #### Device Name VITEK® 2 AST-Gram Negative Levofloxacin (50.125 - ≥8 µg/mL) #### Indications for Use (Describe) VITEK® 2 AST-Gram Negative Levolloxacin 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 vito susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Levofloxacin is a quantitative test. Levolloxacin 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: Enterchacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens Active in vitro but clinical significance unknown: Citrobacter freundii, Enterobacter aerogenes, Klebsiella oxytoca, Morganii, Pantoea agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii VITEK® 2 AST-Gram Negative Levofloxacin also reports the susceptibility for the following additional organism as listed on the FDA Susceptibility Test Interpretive Criteria website: Salmonella 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. | Type of Use (Select one or both, as applicable) | |---------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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}------------------------------------------------ ### 510(k) SUMMARY B. C. ## VITEK® 2 AST-GN Levofloxacin #### 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: | August 4, 2022 | | Formal/Trade Name: | VITEK® 2 AST-Gram Negative Levofloxacin (≤ $0.125 -≥8$ µg/mL) | | Classification Name: | 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Product Code LON, LTT, LTW. | | Common Name: | VITEK® 2 AST-GN Levofloxacin | | Predicate Device: | VITEK® 2 AST-Gram Negative Levofloxacin (K072038) | #### 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 (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 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 {4}------------------------------------------------ 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-GN Levofloxacin has the following concentrations in the card: 0.25, 0.5, 2, and 8 (equivalent standard method concentration by efficacy in ug/mL). ## E. Substantial Equivalence Information The similarities and differences of the VITEK 2 AST-GN Levofloxacin when compared to the predicate device, VITEK 2 AST-GN Levofloxacin (K072038), are described in the following table. The only difference between both devices are the Indications for Use and the breakpoints used to analyze the data performance. The below table provides the similarities and differences: | Item | Device: VITEK® 2 AST-GN Levofloxacin | Predicate: VITEK® 2 AST-GN Levofloxacin (K072038) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Similarities | | | Intended Use | VITEK® 2 AST-Gram Negative Levofloxacin 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 Levofloxacin is a quantitative test. Levofloxacin 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 Levofloxacin 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 Levofloxacin is a quantitative test. Levofloxacin 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: Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens | Active in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens Citrobacter koseri Citrobacter freundii Enterobacter aerogenes | | | Active in vitro but clinical significance unknown | | | Citrobacter koseri Citrobacter freundii Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Pantoea agglomerans Proteus vulgaris Providencia rettgeri Providencia stuartii 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. | Klebsiella oxytoca Morganella morganii Pantoea agglomerans Proteus vulgaris Providencia rettgeri Providencia stuartii The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to for use with the VITEK® 2 and VITEK ® 2 Compact Systems 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 . | | | 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 Gram-negative bacilli. | Same | | Antimicrobial Agent | Levofloxacin | Same | | Inoculum | Saline suspension of organism | Same | | Test Card | VITEK® 2 Gram-negative Susceptibility Test Card | Same | | Analysis Algorithms | Discriminant Analysis | Same | | Instrument | VITEK® 2 and VITEK® 2 Compact Systems | Same | | Concentrations | 0.25, 0.5, 2, 8 | Same | | Differences | | | | Indications for Use | VITEK® 2 AST-Gram Negative Levofloxacin also reports the susceptibility for the following additional organism as listed on the FDA Susceptibility Test Interpretive Criteria website: Salmonella spp. | Acinetobacter baumannii Acinetobacter hvoffii Enterobacter sakazakii Pseudomonas fluorescens | | Breakpoints | Enterobacterales : ≤0.5 (S), 1 (I), ≥2 (R) Pseudomonas aeruginosa : ≤1 (S), 2 (I), ≥4 (R) Salmonella spp.: ≤0.125 (S), 0.25-1 (I), ≥2 (R) | Acinetobacter : ≤2 (S), 4 (I), 8 (R) Enterobacteriaceae : ≤2 (S), 4 (I), 8 (R) Pseudomonas : ≤2 (S), 4 (I), 8 (R) | {5}------------------------------------------------ F. Intended Use: {6}------------------------------------------------ VITEK® 2 AST-Gram Negative Levofloxacin 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 Levofloxacin is a quantitative test. Levofloxacin 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: Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens Active in vitro but clinical significance unknown: - Citrobacter koseri Citrobacter freundii Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Pantoea agglomerans Proteus vulgaris Providencia rettgeri Providencia stuartii VITEK® 2 AST-Gram Negative Levofloxacin also reports the susceptibility for the following additional organism as listed on the FDA Susceptibility Test Interpretive Criteria website: ## Salmonella 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: VITEK® 2 AST-GN Levofloxacin demonstrated substantially equivalent performance when compared with the CLSI agar dilution reference method, as defined in the FDA Class II {7}------------------------------------------------ Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009). The Premarket Notification (Traditional 510[k]) presents data in support of VITEK® 2 AST-GN Levotloxacin. 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 Levofloxacin by comparing its performance with the CLSI agar dilution reference method incubated between 16-20 hours. The data is representative of performance on both the VITEK 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Levofloxacin demonstrated acceptable performance as presented in the table below. | Antimicrobial | An imicrobial Code | Antibiotic Version | Bp1 | Comment | Essential Agreement | | | Category Agreement | | | | % Reproducibility | | |---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---------------|-----------------------------------|---------------------|-----|-----|--------------------|-------------------|---------------|----------------|-------------------|-----| | | | | | | % Error | | | % Error | | | | | | | | | | | | % EA | VME | ME | mE | % CA | VME | ME | mE | | | Levofloxacin | LEV | lev02n | CLSI (FDA) | #, E Enterobacterales | (345/34 6) 99.7 | N/A | N/A | N/A | (339/346) 98.0 | (0/76) 0.0 | (0/262) 0.0 | (7/346) 2.0 | 100 | | | | | | #, E Pseudomonas aeruginosa | (218/22 5) 96.9 | N/A | N/A | N/A | (210/225) 93.3 | (0/76) 0.0 | (2/127) 1.6 | (13/225) 5.8 | | | | | | | #, E Salmonella spp. | (47/48) 97.9 | N/A | N/A | N/A | (47/48) 97.9 | (0/4) 0.0 | (0/40) 0.0 | (1/48) 2.1 | | | | VITEK 2 Levofloxacin MIC values for Escherichia coli, Klebsiella pneumoniae pneumoniae, and Pseudomonas aeruginosa tended to be in exact agreement or at least one doubling dilution higher when compared to the reference agar dilution method. VITEK 2 Levofloxacin MIC values for Serratia marcescens tended to be in exact agreement or at least one doubling dilution lower when compared to the reference agar dilution method. | | | | | | | | | | | | | Abbreviations - Bp = breakyout comminee; EA = essental agreement; CA = category agreement; VME = Very Major Error (suscept with reference readt); ME Major Erro (resistantes until); n.E = mor Error (susceptble or resistant result with an micronation reference result, or an intermediate result with a susceptible or resistent reference result) #=US Food and Drug Administration 510(k) cleared CI.SI = Clinical and Laboratory Standards Insti E = External performance data N/A = Not applicable Reproducibility and Quality Control demonstrated acceptable results. ## H. Conclusion: The performance data presented in this submission support a substantial equivalence decision. VITEK® 2 AST-Gram Negative Levofloxacin (≤0.125 ->8 µg/mL) is substantially equivalent to VITEK® 2 AST-Gram Negative Levofloxacin (K072038). {8}------------------------------------------------ ## 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.

VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)

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VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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