VITEK 2 GRAM POSITIVE DOXCYCLINE

• K Number: K093076
• Device Name: VITEK 2 GRAM POSITIVE DOXCYCLINE
• Manufacturer: BIOMERIEUX, INC.
• Date Cleared: 2010-10-21 ( 386 days)
• Product Code: LON
• Regulation Number: 866.1645

Intended Use

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.

Predicate Devices

VITEK 2 Gram Positive Daptomcyin (K091126)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on automated quantitative/qualitative susceptibility testing using miniaturized dilution techniques and monitoring growth, with no mention of AI or ML algorithms for analysis or interpretation.

Therapeutic

No.
The device is a laboratory aid for determining the susceptibility of microorganisms to antimicrobial agents, rather than directly treating or preventing disease in a patient.

Diagnostic

Yes

Explanation: The device is designed for "antimicrobial susceptibility testing of Gram positive microorganisms" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This testing determines the susceptibility of microorganisms to antibiotics, which is a diagnostic function to guide treatment.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components (VITEK 2 AST Cards, VITEK 2 and VITEK 2 Compact Systems) and a physical process (diluting bacterial isolates, filling and sealing cards, incubation). While software is involved in monitoring growth and generating reports, the core of the device is a hardware-based system for antimicrobial susceptibility testing.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use explicitly states it is "designed for antimicrobial susceptibility testing of Gram positive microorganisms" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
• Device Description: The description details a method for testing bacterial isolates outside the human body using a miniaturized microdilution technique.
• Function: The device determines the susceptibility of microorganisms to antimicrobial agents by testing them in a laboratory setting, not within a living organism.

Therefore, based on the provided information, the VITEK 2 Gram Positive Doxycycline is clearly an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

LON

Device Description

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 - 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Essential Agreement: 99.2%
Category Agreement: 96.6%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

VITEK 2 Gram Positive Daptomcyin (K091126)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.”

Summary

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K093076

Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of the company name in all caps, with a stylized graphic above it. The graphic is a circle split in half, with one half filled with vertical lines and the other half solid black, and a curved line running through the center of the circle.

510(k) SUMMARY

OCT 2 1 2010

VITEK® 2 Gram Positive Doxycycline

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum Road
Hazelwood, MO 63042
Contact Person:	Jolyn Tenllado
Senior 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 Cycle
Antimicrobial 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:

B.

C.

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.

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

bioMérieux, Inc.

Phone: [phone] Anglum Road, Hazelwood, Missouri 63042-2320, USA Fax: [phone]

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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 antimicrobial
susceptibility 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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1050. 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 [phone]. 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 [phone] or [phone] 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:

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.

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

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KD9 3076