VITEK 2 GRAM POSITIVE DOXCYCLINE

K093076 · bioMerieux, Inc. · LON · Oct 21, 2010 · Microbiology

Device Facts

• Record ID: K093076
• Device Name: VITEK 2 GRAM POSITIVE DOXCYCLINE
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Oct 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

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 Story

VITEK 2 Gram Positive Doxycycline is an antimicrobial susceptibility test (AST) card used with VITEK 2/VITEK 2 Compact systems; laboratory aid for determining in vitro susceptibility of Gram-positive microorganisms (Staphylococcus aureus). Input: isolated bacterial colonies diluted in saline; rehydrates antimicrobial medium in card. Operation: VITEK 2 system automatically fills, seals, and incubates; VITEK 2 Compact uses manual filling/sealing. System monitors growth in card wells over 18 hours; compares to doubling dilution technique (MIC). Output: report containing MIC value and interpretive category result. Used in clinical laboratories by trained personnel. Benefits: provides standardized, automated susceptibility testing to guide clinical antibiotic selection.

Clinical Evidence

Bench testing only. Performance evaluated using clinical isolates, challenge strains, quality control, and reproducibility strains. Compared against CLSI broth microdilution reference method. Results: 99.2% overall Essential Agreement and 96.6% overall Category Agreement. Reproducibility and Quality Control met acceptance criteria.

Technological Characteristics

Miniaturized doubling dilution (MIC) microdilution methodology. Card-based system for automated incubation and optical growth monitoring. Compatible with VITEK 2 (automated) and VITEK 2 Compact (manual fill/seal) platforms. Connectivity: Integrated with VITEK 2 system software.

Indications for Use

Indicated for antimicrobial susceptibility testing of isolated Gram-positive colonies, specifically Staphylococcus aureus, using VITEK 2 and VITEK 2 Compact systems. For prescription use only.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• VITEK 2 Gram positive Daptomycin (k091126)

Submission Summary (Full Text)

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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 Road<br>Hazelwood, MO 63042 |
| Contact Person: | Jolyn Tenllado<br>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<br>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<br>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