VITEK 2 COMPACT

K050002 · bioMerieux, Inc. · LON · Feb 17, 2005 · Microbiology

Device Facts

• Record ID: K050002
• Device Name: VITEK 2 COMPACT
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Feb 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

VITEK® 2 Compact System is intended to be used with VITEK® 2 AST Cards for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae and S. pneumoniae. It is intended for use as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Antimicrobials presented in VITEK 2 AST Cards are 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.

Device Story

VITEK® 2 Compact System performs automated identification and antimicrobial susceptibility testing (AST) of bacteria and yeasts. Input: isolated colonies inoculated into saline, density-adjusted via DENSICHECK, and loaded into 64-well AST cards. Operation: vacuum-filled cards placed in cassettes; carousel incubation at 35.5°C; automated optical reading every 15 minutes using 660 nm LEDs and silicon photodetectors to measure turbidity/growth. System includes workstation PC, printer, and Advanced Expert System (AES) for phenotype detection and therapeutic guidance. Output: AST results, identification reports, and QC data. Used in clinical laboratories; operated by lab technicians. Bidirectional interface transfers results to LIS. Benefits: standardized, automated susceptibility testing; rapid phenotype detection; improved clinical decision-making for antimicrobial therapy.

Clinical Evidence

External evaluations conducted at six sites using challenge, reproducibility, and quality control samples for gram-negative and gram-positive organisms. Results: 99.4% agreement for challenge testing vs. VITEK 2; 100% essential agreement for reproducibility; 97.79% essential agreement for precision dilution differences; 99.04% in-range for quality control.

Technological Characteristics

Automated short-term incubation system. Uses VITEK 2 AST cards (miniaturized doubling dilution). Sensing principle: optical scanner measuring light attenuation. Connectivity: automated reporting. Software: automated growth monitoring and MIC calculation.

Indications for Use

Indicated for automated quantitative or qualitative antimicrobial susceptibility testing of isolated colonies of clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

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 System (N50510/S82)

Submission Summary (Full Text)

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FEB 7 2005

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1050002

## 510(k) SUMMARY

## VITEK® 2 Compact

### 510(k) Submission Information:

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Nancy Weaver<br>Staff Regulatory Affairs Specialist |
| Phone Number: | 314-731-8695 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | December 30, 2004 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Compact |
| Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device,<br>21 CFR 866.1645 |
| Common Name: | VITEK 2 Compact System |
| C. Predicate Device: | VITEK® 2 System (N50510/S082) |

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

B

VITEK® 2 Compact System is intended to be used with VITEK® 2 AST Cards for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae and S. pneumoniae. It is intended for use as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Antimicrobials presented in VITEK 2 AST Cards are 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 AST card. The cards are filled with a vacuum filling process, sealed and placed into the reader/incubator. The VITEK 2 Compact monitors growth based on attenuation of light measured by an optical scanner over a defined period of time (up to 18 hours). At the

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completion of the incubation cycle, a report is generated that contains the MC value Our pleation of the interpretive category result for each antibiotic contained on the VITEK 2 AST Card.

The VITEK 2 Compact demonstrated substantially equivalent performance when He VITEK 2 System. The Premarket Notification (510[k]) presents data in support of VITEK 2 Compact System. External evaluations were conducted with at six in support of VTER 2 Tompatic of challenge, reproducibility and quality control for both gram-negative and gram-positive organisms. The VITEK 2 Compact control for both grain negative and of 99.4% for challenge testing when compared to the VITEK 2. Reproducibility was 100% essential agreement when comparing median virent z. Noproducilling the VITEK 2 System. Precision dilution differences comparing individual results to the instrument median demonstrated 97.79% essential companing increation to the new in range for quality control was 99.04%.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

FEB 1 7 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nancy Weaver Staff Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320

k050002 Re: Trade/Device Name: VITEK® 2 Compact 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: December 30, 2004 Received: January 3, 2005

Dear Ms. Weaver:

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, listing 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) This letter witi anow you to ogin manical equivalence of your device of your device to a legally premarket notification: "The sults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you desire specific into this in advertising of your device, please contact the Office of In of questions on the prome Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tou may obtain other general information on your responsibilities under the Act from the Tou may obtain of Scherers, 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,

Sales, a Form

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): K050002

VITEK® 2 Compact Device Name:

Indications For Use:

The VITEK® 2 Compact is intended to be used for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococus 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)

Hoeym Wht
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Office of In Vitro Diagnostic Device Evaluation and Safety

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VITEK® 2 Compact 510(k) Volume 1: p. 9