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 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).

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the VITEK® 2 AST-Gram Positive Moxifloxacin, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "acceptable performance" statement and the presented data tables. The device's performance is compared against the CLSI (Clinical and Laboratory Standards Institute) agar dilution reference method.

Metric (Agreement Type)	Acceptance Criteria (Implied)	Reported Device Performance	Microorganism	Notes
Essential Agreement (EA)	Not explicitly stated, but high EA is expected for "acceptable performance."	98.7%	Enterococcus faecalis	Refers to agreement between the VITEK® 2 MIC value and the CLSI reference MIC.
Category Agreement (CA)	Not explicitly stated, but high CA is expected for "acceptable performance."	99.4%	Enterococcus faecalis	Refers to agreement in interpretive categories (Susceptible, Intermediate, Resistant).
Very Major Errors (VME)	Low percentage desired.	0.0% (0/43)	Enterococcus faecalis	Occurs when the VITEK® 2 calls an isolate susceptible but the reference method calls it resistant.
Major Errors (ME)	Low percentage desired.	0.0% (0/110)	Enterococcus faecalis	Occurs when the VITEK® 2 calls an isolate resistant but the reference method calls it susceptible.
Minor Errors (mE)	Low percentage desired.	0.6% (1/154)	Enterococcus faecalis	Occurs when the VITEK® 2 calls an isolate susceptible/resistant and the reference method calls it intermediate, or vice versa, or when both call it intermediate but with different MICs.
Essential Agreement (EA)	Not explicitly stated, but high EA is expected for "acceptable performance."	94.9%	Staphylococcus spp.	Refers to agreement between the VITEK® 2 MIC value and the CLSI reference MIC.
Category Agreement (CA)	Not explicitly stated, but high CA is expected for "acceptable performance."	99.4%	Staphylococcus spp.	Refers to agreement in interpretive categories (Susceptible, Intermediate, Resistant).
Very Major Errors (VME)	Low percentage desired.	4.8% (16/331)	Staphylococcus spp.	Occurs when the VITEK® 2 calls an isolate susceptible but the reference method calls it resistant.
Major Errors (ME)	Low percentage desired.	0.7% (1/152)	Staphylococcus spp.	Occurs when the VITEK® 2 calls an isolate resistant but the reference method calls it susceptible.
Minor Errors (mE)	Low percentage desired.	0.0% (0/163)	Staphylococcus spp.	Occurs when the VITEK® 2 calls an isolate susceptible/resistant and the reference method calls it intermediate, or vice versa, or when both call it intermediate but with different MICs.
Reproducibility	Not explicitly stated, but 100% is shown for Quality Control.	100.0%	Enterococcus faecalis Quality Control	Demonstrated acceptable results.
Reproducibility	Not explicitly stated, but 100% is shown for Quality Control.	N/A (Not specified for Staphylococcus spp. Quality Control)	Staphylococcus spp. Quality Control	Demonstrated acceptable results.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Enterococcus faecalis: 154 isolates for overall agreement metrics. (Breakdown for VME/ME shows 43 for VME calculation, 110 for ME calculation, so the total number of isolates tested could be higher than 154 if not all isolates were discrepant in a way that led to VME or ME.)
- Staphylococcus spp.: 331 isolates for overall agreement metrics. (Breakdown for VME/ME shows 331 for VME calculation, 152 for ME calculation, 163 for mE calculation, similar note applies as above).
Data Provenance: "External evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains." This indicates a mix of retrospective (stock/challenge strains) and prospective (fresh clinical isolates) data. The document does not specify the country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The ground truth is established by the CLSI agar dilution reference method, which is a standardized laboratory procedure, not typically by individual human experts evaluating images or making subjective interpretations.

4. Adjudication Method for the Test Set

This information is not applicable in the context of an antimicrobial susceptibility test where the ground truth is established by a reference laboratory method (CLSI agar dilution). There is no "adjudication" in the sense of multiple human readers resolving discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable as the device is an automated antimicrobial susceptibility system, not an AI-assisted diagnostic imaging tool for human readers. There is no human-in-the-loop component for interpretive decisions that would necessitate an MRMC study.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this was a standalone performance evaluation. The VITEK® 2 system, which incorporates "Analysis Algorithms" (Discriminant Analysis), determines the MIC and interpretive category without human interpretive input. The study compared the device's automated results directly against the CLSI reference method.

7. The Type of Ground Truth Used

The ground truth used was the CLSI agar dilution reference method. This is a well-established, standardized laboratory method for determining the minimum inhibitory concentration (MIC) of an antimicrobial agent against a microorganism. It's a gold standard for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set

This information is not provided in the document. The document describes the performance evaluation of the VITEK® 2 AST-GP Moxifloxacin system, which uses "Discriminant Analysis" algorithms. While algorithms often require training data, the specific training set size is not detailed in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document. Given that the device uses "Discriminant Analysis" and is based on microdilution techniques, it's highly likely that the training process involved internal laboratory data where a similar reference method (like CLSI agar dilution) was used to establish the ground truth for calibrating and optimizing the system's interpretive algorithms. However, the document does not specify this.

Summary

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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

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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

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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

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)

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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 RoadHazelwood, MO 63042
Contact Person:	Cherece L. JonesStaff 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 - ≥8µg/mL)
Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial 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:

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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
IntendedUse/Indications for Use	VITEK® 2 AST-Gram PositiveMoxifloxacin is designed forantimicrobial susceptibility testing ofGram positive microorganisms and isintended for use with the VITEK® 2and VITEK® 2 Compact Systems asa laboratory aid in the determinationof in vitro susceptibility toantimicrobial agents. VITEK® 2AST-Gram Positive Moxifloxacin isa quantitative test. Moxifloxacin hasbeen shown to be active against moststrains of the microorganisms listedbelow, according to the FDA labelfor this antimicrobial.Active both in vitro and in clinicalinfections:Enterococcus faecalis	VITEK 2® Gram PositiveMoxifloxacin is designed forantimicrobial susceptibility testing ofStaphylococcus aureus (methicillin-susceptible strains only). It is intendedfor use with the VITEK 2® System asa laboratory aid in the determinationof in vitro susceptibility toantimicrobial agents.The VITEK® 2 Gram PositiveSusceptibility Card is intended for usewith the VITEK® 2 System in clinicallaboratories as an in vitro test todetermine the susceptibility ofStaphylococcus spp., Enterococcusspp., and S. agalactiae toantimicrobial agents when used asinstructed in the Online Product

Table 1: Substantial Equivalonco

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New Device andPredicate 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 theirclinical significance is unknown:Staphylococcus epidermidis
	The VITEK® 2 Gram-positiveSusceptibility Card is intended foruse with the VITEK® 2 Systems inclinical laboratories as an in vitro testto determine the susceptibility ofStaphylococcus spp., Enterococcusspp., and S. agalactiae toantimicrobial agents when used asinstructed.
Test Methodology	Automated quantitative antimicrobialsusceptibility test for use with theVITEK® 2 and VITEK® 2 CompactSystems to determine the in vitrosusceptibility 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 CompactSystems	Same
General Device Characteristic Differences
Breakpoints	Enterococcus faecalisS ≤ 1, I 2, ≥ 4RStaphylococcus spp.S ≤ 0.5, I 1, ≥ 2R	Staphylococcus spp.S ≤ 2, I 4, ≥ 8R

F. Intended Use:

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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

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:

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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. faecalisATCC®29212™	S. aureusATCC®29213™
Moxifloxacin	mxf02n	≤ 0.25 - 0.5⁰(FDA/CLSI QCrange is 0.06 –0.5)	≤ 0.25⁰(FDA/CLSI QCrange 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.
1. 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

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1. Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, Philadelphia, PA, 1976.

Regulation Number and Section

§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

(a)
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.(b)
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.”