VITEK® 2 AST-Gram Positive Telavancin 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 Telavancin is a quantitative test. Telavancin 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 Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis (vancomycin-susceptible isolates only)

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 an analysis of the provided text regarding the VITEK 2 AST-GP Telavancin device, broken down by your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit for AST Systems per FDA Guidance)	Reported Device Performance (VITEK® 2 AST-GP Telavancin)	Organism(s)
Essential Agreement (%EA)	≥ 90% (Typically for AST devices)	89.9% (331/368)	Enterococcus faecalis
		94.2% (490/520)	Staphylococcus aureus
Category Agreement (%CA)	≥ 90% (Typically for AST devices)	92.9% (342/368)	Enterococcus faecalis
		98.8% (514/520)	Staphylococcus aureus
Very Major Errors (VME)	Low rate (e.g., < 1.5% - < 3% for AST devices)	0.0% (0/1)	Enterococcus faecalis
		0.0% (0/0)	Staphylococcus aureus
Major Errors (ME)	Low rate (e.g., < 1.5% - < 3% for AST devices)	7.1% (26/367) *Adjusted to 5.7%	Enterococcus faecalis
		1.2% (6/520)	Staphylococcus aureus
Minor Errors (mE)	Low rate (e.g., < 1.5% - < 3% for AST devices)	N/A (not explicitly reported by organism)	Enterococcus faecalis, Staphylococcus aureus
Reproducibility	High (e.g., typically ≥ 95% for AST devices)	100.0%	Staphylococcus aureus
Quality Control (QC)	Acceptable results	Acceptable results	Not specified

Notes on Acceptance Criteria:

The document explicitly states the device demonstrated "substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009)." This guidance document outlines the typical performance metrics and acceptable thresholds for AST devices. While the exact numerical criteria are not given in this summary, they are implicitly met if the FDA clears the device. Common thresholds for these metrics are generally around >90% for EA and CA, and low rates (e.g., <3%) for VME and ME.
For Enterococcus faecalis, the document notes that five major errors were within essential agreement, and due to the lack of an intermediate breakpoint, these were considered acceptable. This adjusted the major error rate for E. faecalis to 5.7%, with a requirement for retesting non-susceptible strains.

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

Sample Size:
- Enterococcus faecalis: 368 isolates
- Staphylococcus aureus: 520 isolates
- The total number of unique isolates is not explicitly stated if there are overlaps (e.g., some isolates tested for both).
Data Provenance: "An external evaluation was conducted with contemporary and stock clinical isolates, as well as a set of challenge strains." This suggests a mix of retrospective (stock and some clinical) and prospective (contemporary clinical) data. The country of origin is not specified.

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 summary.
For Antimicrobial Susceptibility Testing (AST) devices, the ground truth is typically established by an independent, validated reference method performed by trained microbiologists. The concept of "experts" in the context of expert consensus or adjudication (as in medical imaging) is generally not directly applicable to the establishment of ground truth for AST, where a standardized laboratory method (CLSI broth microdilution) serves as the "gold standard."

4. Adjudication Method for the Test Set

This information is not applicable in the traditional sense of human adjudication for AST devices. The "adjudication" is inherent in the comparison of the device's Minimum Inhibitory Concentration (MIC) and interpretive category (Susceptible, Intermediate, Resistant) with the results from the CLSI broth microdilution reference method. Discrepancies are categorized as Essential Agreement, Category Agreement, VME, ME, or mE. The document mentions an adjustment for E. faecalis major errors due to breakpoint interpretation, which is an analytical decision, not a human reader adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to this device. The VITEK 2 AST system is an automated in vitro diagnostic device for antimicrobial susceptibility testing, not an AI-powered diagnostic imaging tool that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was done. The VITEK® 2 AST-GP Telavancin is an automated system. Its performance was directly compared against the CLSI broth microdilution reference method without human intervention in the interpretation of the VITEK 2 results during the performance study. This comparison establishes the "algorithm only" performance.

7. The Type of Ground Truth Used

CLSI broth microdilution reference method incubated at 16-20 hours for Staphylococci and Enterococci, and 20-24 hours for Streptococci. This is a laboratory-based reference standard widely accepted as the gold standard for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set

The document does not explicitly state a separate "training set" sample size or method. For AST systems like VITEK 2, the "training" (i.e., development and optimization of the growth pattern analysis algorithm) would have occurred during the initial development of the VITEK 2 platform itself and may not be a distinct "training set" for each new antimicrobial/organism combination. The external evaluation described serves as the validation/test set.

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

As a training set is not explicitly mentioned for this specific antimicrobial, the method for establishing ground truth for any underlying algorithm development is not detailed in this summary. However, for AST devices, any algorithm development would typically rely on extensive data where the MICs and interpretive categories were determined by the same CLSI broth microdilution reference method.

Summary

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August 8, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The seal features an eagle with its wings spread, and the FDA part includes the acronym in a blue square and the full name "U.S. Food & Drug Administration" in blue text.

bioMérieux, Inc Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042

Re: K212243

Trade/Device Name: VITEK 2 AST- Gram Positive Telavancin (≤0.015 - ≥1 µg/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, LTT, LTW Dated: July 14, 2021 Received: July 19, 2021

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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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.

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics 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)

K212243

Device Name

VITEK® 2 AST-GP Telavancin (<0.015 - >1 ug/mL)

Indications for Use (Describe)

Active both in vitro and in clinical infections Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis (vancomycin-susceptible isolates only)

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 Telavancin (≤0.015 - ≥1 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:	July 14, 2021
Device Name:
Formal/Trade Name:	VITEK® 2 AST Gram-Positive Telavancin (≤0.015 - ≥1µg/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 Telavancin (≤0.015 - ≥1 µg/mL)
Predicate Device:	VITEK® 2 AST- GP Dalbavancin (≤0.015 - ≥1 µg/mL)(K190616)

D. Device Description:

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E. Substantial Equivalence Information:

The similarities and differences of the VITEK® 2 AST-GP Telavancin (≤0.015 - ≥1 µg/mL) when compared to the predicate device, VITEK® 2 AST-GP Dalbavancin (≤0.015 - ≥1 µg/mL) (K190616), are described in the Table 1 below.

Item	Device:VITEK® 2 AST-GP Telavancin(≤0.015 - ≥1 µg/mL)	Predicate:VITEK® 2 AST-GP Dalbavancin(≤0.015 - ≥1 µg/mL) (K190616)
Similarities
Intended Use	VITEK® 2 AST-Gram PositiveTelavancin 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 Telavancin is aquantitative test. Telavancin has beenshown to be active against moststrains of the microorganisms listedbelow, according to the FDA labelfor this antimicrobial.Active both in vitro and in clinicalinfectionsStaphylococcus aureus (includingmethicillin-resistant isolates)Enterococcus faecalis (vancomycin-	VITEK® 2 AST-Gram PositiveDalbavancin is designed forantimicrobial susceptibility testing ofGram positive microorganisms and isintended for use with the VITEK® 2and VITEK® 2 Compact Systems as alaboratory aid in the determination ofin vitro susceptibility to antimicrobialagents. VITEK® 2 AST-Gram PositiveDalbavancin is a quantitative test.Dalbavancin has been shown to beactive against most strains of themicroorganisms listed below,according to the FDA label for thisantimicrobial.Active both in vitro and in clinicalinfectionsStaphylococcus aureus (includingmethicillin-resistant isolates)Enterococcus faecalis (vancomycin-

Table 1: Substantial Equivalence

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Item	Device:VITEK® 2 AST-GP Telavancin(≤0.015 - ≥1 µg/mL)	Predicate:VITEK® 2 AST-GP Dalbavancin(≤0.015 - ≥1 µg/mL) (K190616)
Similarities
	susceptible isolates only)	susceptible isolates only)Streptococcus agalactiae
	The VITEK® 2 Gram-positiveSusceptibility Card is intended for usewith the VITEK® 2 Systems in clinicallaboratories as an in vitro testto determine the susceptibility ofStaphylococcus spp., Enterococcusspp., and S. agalactiae toantimicrobial agents when used asinstructed.	The VITEK® 2 Gram-positiveSusceptibility Card is intended for usewith the VITEK® 2 Systems in clinicallaboratories 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
Inoculum	Saline suspension of organism	Same
Test Card	Gram-Positive (AST-GP)Susceptibility Card	Same
Analysis Algorithms	Growth Pattern Analysis	Same
Instrument	VITEK® 2 and VITEK® 2 CompactSystems	Same
Differences
Antimicrobial Agent	Telavancin	Dalbavancin
Concentrations	0.015, 0.125, 0.25, 0.5	0.0625, 0.125, 0.25, 0.5

F. Indications for Use:

Active both in vitro and in clinical infections Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis (vancomycin-susceptible isolates only)

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G. Performance Overview and Conclusion:

VITEK® 2 AST-GP Telavancin (≤0.015 - ≥1 ug/mL) demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009).

The Premarket Notification (510|k]) presents data in support of VITEK® 2 AST-GP Telavancin. An external evaluation was conducted with contemporary and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of AST-GP Telavancin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hours for Staphylococci and Enterococci. 20-24 hours for Streptococci. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.

The VITEK® 2 AST-GP Telavancin (≤0.015 - ≥1 µg/mL) demonstrated acceptable performance as presented in Table 2 below:

Antimicrobial	Comment	Essential Agreement Category				Category Agreement				% Reproducibility
		% Error				% Error
		%EA	VME	ME	mE	%CA	VME	ME	mE
	#, EEnterococcusfaecalis	89.9(331/368)	N/A	N/A	N/A	92.9(342/368)	0.0(0/1)	7.1(26/367)*	N/A
Telavancin	#,EStaphylococcusaureus	94.2(490/520)	N/A	N/A	N/A	98.8(514/520)	0.0(0/0)	1.2(6/520)	N/A	100.0
	* Five major errors for Enterococcus faecalis were within essential agreement with the reference method; due tothe lack of an intermediate breakpoint these five major errors were considered acceptable and the major error rateis adjusted to 5.7% which will still require retesting of non-susceptible strains with an alternate method.VITEK 2 AST-Gram Positive Telavancin MIC values tended to be in exact agreement or at least one doublingdilution higher when testing E. faecalis, and S. aureus compared to the CLSI reference broth microdilutionmethod.

Table 2: VITEK® 2 AST-GP Telavancin Performance

Kev:

# = US Food and Drug Administration 510(k) cleared

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E = External performance data

Quality Control demonstrated acceptable results.

H. References:

1. MacLowry, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic Sensitivity Testing in the Clinical laboratory, Journal of Laboratory Clinical Medicine, 72:685-687, 1968.
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.
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.”