The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. VITEK 2 Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Enterococcus faecium, Staphylococcus epidermidis and Staphylococcus haemolyticus. VITEK 2 Gram Positive Daptomycin is a quantitative test. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Device Description

The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology. The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 automatically fills, seals and places the card into the incubator/reader. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). 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 based on the provided text for the VITEK® 2 Gram Positive Daptomycin device:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement (EA)	98.2%
Overall Category Agreement (CA)	100%

Note: The specific numerical acceptance thresholds are not explicitly stated in the provided text, but the reported performance values are presented as demonstrating "acceptable performance" and "substantially equivalent performance" when compared to the reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003.

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical value. The study mentions "fresh and stock clinical isolates and stock challenge strains."
- Data Provenance: Not explicitly stated (e.g., country of origin). The nature ("fresh and stock clinical isolates") suggests real-world patient samples, but the geographic origin is not specified. It was a prospective evaluation in the sense that the VITEK 2 was compared against a reference method in a controlled study design.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The ground truth was established by a recognized reference method, not by expert consensus.
Adjudication method for the test set:
- Not applicable/Not mentioned. Adjudication by experts is not relevant when comparing a device to a defined reference standard method.
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:
- Not applicable. This device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic intended for human reader interpretation improvement. The comparison is between the automated system and a laboratory reference method.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study. The VITEK® 2 system is an automated device designed to "automatically fills, seals and places the card into the incubator/reader" and "monitors the growth of each well... At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result." The study confirms its performance against a reference method without human intervention in the interpretation process of the device results.
The type of ground truth used:
- Expert Consensus/Pathology/Outcomes Data, etc.: The ground truth was established by the NCCLS reference broth microdilution method. This is a laboratory-based, standardized reference method for determining antimicrobial susceptibility.
The sample size for the training set:
- Not applicable/Not mentioned. This device is described as an "essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology." It is a hardware/chemistry-based system with an automated readout, not a machine learning or AI algorithm that requires a separate training set in the conventional sense. Its "training" or calibration would likely involve precise manufacturing and chemical formulation, not a data-driven training set.
How the ground truth for the training set was established:
- Not applicable. As noted above, this device does not appear to rely on a data-driven training set with an established ground truth in the way AI algorithms do.

Summary

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K050075

Image /page/0/Picture/1 description: The image shows the logo for BioMerieux. The logo consists of the word "BIOMERIEUX" in a stylized font. Above the text is a black circle with a design that resembles a tree or plant.

FEB 2 8 2005

510(k) SUMMARY

VITEK® 2 Gram Positive Daptomycin

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jolyn TenlladoRegulatory Affairs Specialist
Phone Number:	314-731-8386
Fax Number:	314-731-8689
Date of Preparation:	January 10, 2005
B. Device Name:
Formal/Trade Name:	VITEK® 2 Gram Positive Daptomycin
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device,21 CFR 866.1645
Common Name:	VITEK 2 AST-GP Daptomycin
C. Predicate Device:	VITEK 2 Gram Positive Susceptibility Test forLinezolid (K032766)

D. 510(k) Summary:

VITEK® 2 Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Enterococcus faecium, Staphylococcus epidermidis and Staphylococcus haemolyticus. 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 antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 automatically fills, seals and places the card into the incubator/reader. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up

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to 18 hours). 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 Gram Positive Daptomycin demonstrated substantially equivalent performance when compared with the NCCLS reference broth microdilution method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003.

The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Daptomycin. An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Daptomycin by comparing its performance with the NCCLS broth microdilution reference method. VITEK 2 Gram Positive Daptomcyin demonstrated acceptable performance of 98.2% overall Essential Agreement and 100% overall Category Agreement when compared to the broth microdilution reference method. Reproducibility and Quality Control demonstrated acceptable results.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

FEB 2 8 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Jolyn Tenllado Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320

K050075 Rc:

KU50073
Trade/Device Name: VITEK® 2 Gram Positive Daptomycin (≤0.5 - ≥16 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: January 10, 2005 Received: January 12, 2005

Dear Ms. Tenllado:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(x) premium is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosals) to regists and ment date of the Medical Device American processes of commerce print to May 20, 1770, in the provisions of the Federal Food, Drug, uevices mat have been resulted mequire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not requent of the general controls provisions of the Act. The 1 ou may, ulciclere, market the act include requirements for annual registration, listing of general controls provisions and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is classified (doo as controls. Existing major regulations affecting your device it may be subject to submadations (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 can be found in Title Brouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that I Drivedants of rour device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must of ally if ederal statutes and regulations ancluding, but not limited to: registration and listing (21 confity with an the Ace 31equirements, on and 809); and good manufacturing practice to CI K Fart 807), labeling (21 Se quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your article of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The FDA miding of bassance of the super and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, of In if you desire specific information avour trising of your device, please contact the Office of In
or questions on the promotion and advertising of your a season of the or questions on the promotion and ad rerrisonig or your and Safety at (2016) 276-0484. Also, please note the CCCD Parl Vitro Diagnostic Device Evaluation and Bareer at (210). And Sun Sun Since in Sun. Act from the regulation entitled, "Misolanding by reisenes we responsibilities under the Act from the You may obtain other general information on your copyour Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (000) 050 = fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sales, a. Forg

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):____K050075

Device Name: VITEK® 2 Gram Positive Daptomycin (<0.5 – ≥16 µg/ml)

Indications For Use:

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the The VITER 2 Antiniorobial Odoophisman itative or qualitative susceptibility testing of VTTEK 2 System for the adtomatod qualificant aerobic gram-negative bacilli, ISolated colonies for the moor cirilisany of Streptococcus agalactiae, and S. Staphylococcas Spp., Enteroooous opp., Directorial is designed for antimicrobial prieumoniae. VITEN 2 Grant Footin & Staphylococcus aureus, Streptococcus aureus, Streptococcus Susceptibility testing of Enterosos Staphylococcus epidermidis and Staphylococcus agalachae, Enterooooooo naoolani, Stup nomitative test. It is intended fraemolyticus. " VTER 2 Gran Pock.ro be proving aid in the determination of in vitro susceptibility to antimicrobial agents.

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Salazar
Division Sign-Off
Office of In Vitro Diagnostic Device

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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.”