VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE

K080201 · bioMerieux, Inc. · LON · Apr 30, 2008 · Microbiology

Device Facts

• Record ID: K080201
• Device Name: VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Apr 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

VITEK® 2 Gram Positive Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus species. VITEK 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test. It 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. 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 spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

Device Story

VITEK®2 AST system uses automated optical monitoring of organism growth in microdilution cards. System inoculates card with standardized organism suspension; incubates; monitors light transmittance periodically to measure growth. Algorithm uses discriminate analysis of growth characteristics to determine susceptibility. If ICR test is positive for Staphylococcus species and clindamycin result is susceptible/intermediate, system forces clindamycin result to resistant. Used in clinical laboratories by technicians; provides automated MIC and category interpretation (SIR) to clinicians to guide antimicrobial therapy. Benefits include rapid, standardized detection of inducible clindamycin resistance.

Clinical Evidence

Performance evaluated using fresh and stock clinical isolates and stock challenge strains. Compared against CLSI Disk Approximation Test reference method. Demonstrated 99.3% overall Category Agreement. Reproducibility and Quality Control results were acceptable. Data supported performance on both VITEK 2 and VITEK 2 Compact platforms.

Technological Characteristics

Miniaturized doubling dilution technique for MIC determination. Automated incubation and optical monitoring of growth in AST cards. Compatible with VITEK 2 and VITEK 2 Compact instrument platforms. Qualitative test for inducible clindamycin resistance.

Indications for Use

Indicated for testing Staphylococcus species for inducible clindamycin resistance using clindamycin (0.5 µg/mL) and clindamycin/erythromycin (0.25/0.5 µg/mL) concentrations on VITEK®2 Gram Positive Susceptibility Cards. 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 Cefoxitin Screen (k053097)

Submission Summary (Full Text)

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K080201

Image /page/0/Picture/1 description: The image shows the logo for BIOMÉRIEUX. The logo consists of the company name in block letters, with a stylized graphic above it. The graphic features a black circle with lines emanating from it, bisected by a curved line.

APR 3 0 2008

#### 510(k) SUMMARY

### VITEK® 2 Gram Positive Inducible Clindamycin Resistance

#### 510(k) Submission Information:

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|-----------------------------------------------------------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Jolyn Tenllado<br>Senior Regulatory Affairs Specialist |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | January 24, 2008 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Inducible Clindamycin<br>Resistance |
| Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device, 21 CFR 866.1645 |
| Common Name: | VITEK 2 AST-GP Inducible Clindamycin Resistance |
| C. Predicate Device: | VITEK 2 Gram Positive Cefoxitin Screen (K053097). |

#### D. 510(k) Summary:

в.

VITEK® 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test designed for antimicrobial susceptibility testing of Staphylococcus species. A positive ICR test is indicative of inducible MLS, resistance, which confers resistance to macrolides, lincosamides, and type B
inducible MLS, resistance, which confers resistance to macrolides, and VITEK® 2 Co 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% - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System belomatically 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 over a delined pend of the (up to To Tronice). It the interpretive category result for each antibiotic contained on the card.

VITEK 2 Gram Positive Inducible Clindamycin Resistance demonstrated substantially equivalent performance when compared with the CLSI Disk Approximation Test reference method, as defined

#### bioMérieux, Inc.

Fax: 314/731-Phone: [phone] Anglum Road, Hazelwood, Missouri 63042-2320, USA 8700

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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 Inducible Clindamycin Resistance. 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 Inducible Clindamycin Resistance by comparing its performance with the CLSI Disk Approximation Test reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK 2 Gram Positive Inducible Clindamycin Resistance demonstrated acceptable performance of 99.3% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.

*Note: This device clinical trial was initiated prior to the March 5, 2007 issuance of the revised guidance, which is why the older guidance document is cited.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## APR 3 0 2008

Mr. John Tenllado Senior Regulatory Affairs Specialist bioMérieux 595 Anglum Road Hazelwood, MO 63042

Re: k080201

> Trade/Device Name: VITEK® 2 Gram Positive Inducible Clindamycin Resistance Regulation Number: 21 CFR § 866.1645 Regulation Name: Antimicrobial Susceptibility Test System -- Short Incubation Regulatory Class: II Product Code: LON Dated: April 17th, 2008 Received: April 18th, 2008

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Sally attaym

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):_k 080201

Device Name: VITEK® 2 Gram Positive Inducible Clindamycin Resistance

Indications For Use:

VITEK® 2 Gram Positive Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus species. VITEK 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test. It 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.

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 spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

Prescription Use X (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 Poole

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Sion Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K08 0201