VITEK 2 Gram Positive Doxycycline 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 Gram Positive Doxycycline is a qualitative test. Doxycycline has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections: Staphylococcus aureus

The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK 2 and VITEK 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gramnegative bacilli, Staphylococcus sp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

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 - 0 .50% 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 and sealing operation. 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 an analysis of the provided text, outlining the acceptance criteria and study details for the VITEK® 2 Gram Positive Doxycycline device:

Acceptance Criteria and Device Performance Study for VITEK® 2 Gram Positive Doxycycline

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to the acceptance criteria outlined in the "FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued March 5, 2007." While the specific numerical thresholds for this guidance document are not explicitly stated in the provided text, the device's performance is reported against these implied criteria.

Performance Metric	Acceptance Criteria (Implied by FDA Guidance)	Reported Device Performance
Overall Essential Agreement	Acceptable (as defined in guidance document)	99.2%
Overall Category Agreement	Acceptable (as defined in guidance document)	96.6%
Reproducibility	Acceptable	Acceptable results
Quality Control	Acceptable	Acceptable results

Note: The exact numerical thresholds for "acceptable" are not provided in the submitted document, but the device states it demonstrated substantially equivalent performance and acceptable performance as defined by the guidance document.

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

Sample Size for Test Set: Not explicitly stated as a single number. The study involved an "external evaluation using the VITEK 2 System conducted with fresh clinical isolates, challenge, quality control and reproducibility strains" and an "external evaluation using the VITEK 2 Compact instrument conducted with challenge, quality control and reproducibility strains."
Data Provenance: The text indicates "fresh clinical isolates" were used. While the country of origin is not explicitly mentioned, bioMérieux, Inc. is based in Hazelwood, MO, USA, suggesting the data is likely from the United States. The evaluations were "external," indicating they were performed outside of the manufacturer's primary internal testing. The study design is prospective in nature, as it involved conducting evaluations with specific protocols.

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

The text does not specify the number of experts used or their qualifications. The ground truth was established by the "CLSI broth microdilution reference method." This method is a standardized laboratory procedure, and while it requires trained personnel to perform, it is not established through expert consensus in the same way, for example, a radiologic diagnosis might be.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable here, as the comparison is against a reference laboratory method (CLSI broth microdilution) rather than expert interpretation or consensus where discrepancies would need to be resolved. Performance metrics (Essential Agreement, Category Agreement) are calculated directly by comparing the device's results to the reference method's results.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility testing (AST) system, not an AI-assisted diagnostic tool for human readers. Its purpose is to automate and provide faster results for antimicrobial susceptibility, replacing or supplementing traditional manual laboratory methods, not to assist human interpretation of complex images or data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The VITEK® 2 system is a "Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Device." The evaluations compare the device's performance directly against the CLSI reference method. While a human initiates the test and interprets the final report, the core susceptibility determination is performed by the automated system (algorithm).

7. The Type of Ground Truth Used

The type of ground truth used was a reference laboratory method: the CLSI broth microdilution reference method. This is considered the gold standard for determining minimum inhibitory concentration (MIC) and susceptibility categories for antimicrobials.

8. The Sample Size for the Training Set

The text does not explicitly mention a "training set" or its sample size. For an automated AST system like VITEK 2, the "training" (or development) of the algorithm to interpret growth patterns and determine MICs would likely occur during its initial design and validation phases. The document focuses on the performance evaluation (test set) of the finalized device.

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

As with the training set itself, the method for establishing ground truth for any internal development or "training" phases is not described in the provided document. However, it is highly probable that the CLSI broth microdilution reference method would have been extensively used during the development and calibration of the VITEK 2 system's algorithms to ensure accurate MIC determination based on microbial growth patterns.

Summary

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K093076

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510(k) SUMMARY

OCT 2 1 2010

VITEK® 2 Gram Positive Doxycycline

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jolyn TenlladoSenior Manager, Regulatory Affairs
Phone Number:	314-731-8386
Fax Number:	314-731-8689
Date of Preparation:	May 3, 2010
Device Name:
Formal/Trade Name:	VITEK 2 Gram Positive Doxycycline (≤4 - ≥ 16 µg/ml)
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR 866.1645
Common Name:	VITEK 2 AST-GP Doxycycline
Predicate Device:	VITEK 2 Gram Positive Daptomcyin (K091126)

D. 510(k) Summary:

VITEK® 2 Gram Positive Doxycycline 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 Gram Positive Doxycvcline is a qualitative test. Doxycycline has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections: Staphylococcus aureus

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.

bioMérieux, Inc.

Phone: 314/731-8500 800/638-4835 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Fax: 314/731-8700

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generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

VITEK 2 Gram Positive Doxycycline 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 March 5, 2007.

This Premarket Notification 510(k) presents data in support of VITEK 2 Gram Positive Doxycycline. This data includes:

. An external evaluation using the VITEK 2 System conducted with fresh clinical isolates. challenge, quality control and reproducibility strains per the Clinical Trial Protocol requirements.
An external evaluation using the VITEK 2 Compact instrument conducted with challenge, . quality control and reproducibility strains per the Equivalency Trial Protocol requirements.

The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Doxycycline by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 Compact instrument platforms. VITEK 2 Gram Positive Doxycycline demonstrated acceptable performance of 99.2% overall Essential Agreement and 96.6% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results using both the VITEK 2 Compact instrument systems.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

BIOMÉRIEUX
c/o John Tenllado
Senior Manager, Regulatory Affairs
595 Anglum Road	OCT 2 1 2010
Hazelwood, MO 63042
Re:	K093076
Trade/Device Name:	VITEK®2 Gram Positive Doxycycline
Regulation Number:	21CFR §862.1645
Regulation Name:	Fully automated short-term incubation cycle antimicrobialsusceptibility system.
Regulatory Class:	Class II
Product Code:	LON
Dated:	May 3, 2010
Received:	May 4, 2010

Dear Mr. Tenllado:

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. The v general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Liddie tu. Poole, ins

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):_K093076

Device Name: VITEK® 2 Gram Positive Doxycycline (≤ 4 - ≥ 16 µg/ml)

Indications For Use:

Active in vitro and in clinical infections: Staphylococcus aureus

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)

Freddie Lee Poole

Division Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KD9 3076

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.”