VITEK 2 GRAM NEGATIVE TIGECYCLINE

K052311 · bioMerieux, Inc. · LON · Sep 29, 2005 · Microbiology

Device Facts

• Record ID: K052311
• Device Name: VITEK 2 GRAM NEGATIVE TIGECYCLINE
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Sep 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

VITEK®2 Gram Negative Tigecycline is intended for antimicrobial susceptibility testing of Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Citrobacter koseri, Enterobacter aerogenes, and Serratia marcescens. VITEK 2 Gram Negative Tigecycline is a qualitative test. It is intended for use with the VITEK 2 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 gram-negative bacilli and Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

Device Story

VITEK® 2 system performs automated antimicrobial susceptibility testing (AST) for aerobic gram-negative bacilli. Input: isolated bacterial colonies suspended in saline (McFarland 0.5 standard). Process: VITEK® 2 instrument automatically fills, seals, and incubates test cards containing antibiotic-impregnated microwells; optical sensors measure light transmittance every 15 minutes to monitor growth kinetics. Algorithm: discriminate analysis of growth parameters determines Minimum Inhibitory Concentration (MIC) and categorical interpretation (S/I/R). Output: MIC values and susceptibility categories. Used in clinical laboratories by technicians/microbiologists. Benefits: rapid, automated susceptibility determination to guide antibiotic therapy.

Clinical Evidence

Method comparison study against CLSI M7 agar dilution reference method using 394 clinical and challenge isolates of Enterobacteriaceae. Results: 91.9% Category Agreement (CA). Minor discrepancies: 28; Major discrepancies: 4; Very major discrepancies: 0. Reproducibility >95%. No clinical data (patient outcomes) provided; bench testing only.

Technological Characteristics

Miniaturized AST card containing antimicrobial medium. Sensing principle: automated optical monitoring of bacterial growth in wells over 18 hours. System: VITEK 2 or VITEK 2 Compact. Connectivity: integrated with VITEK 2 system software for automated reporting. Sterilization: not specified.

Indications for Use

Indicated for testing appropriate Enterobacteriaceae using the VITEK® 2 gram negative susceptibility card to determine susceptibility to Tigecycline (concentrations 0.75, 2, and 4; calling range ≤0.5-≥8μg/mL). 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 Negative AST Panel for Ertapenem (K041982)

Submission Summary (Full Text)

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K0523//

## 510(k) SUMMARY

### VITEK® 2 Gram Negative Tigecycline

#### 510(k) Submission Information:

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Jolyn Tenllado<br>Regulatory Affairs Specialist |
| Phone Number: | 314 -731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | August 23, 2005 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Negative Tigecycline (≤0.5 - ≥8<br>µg/ml) |
| Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device, 21 CFR<br>866.1645 |
| Common Name: | VITEK 2 AST-GN Tigecycline |
| Predicate Device: | VITEK 2 Gram Negative Ertapenem (K041982) |

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

B.

C.

VITEK® 2 Gram Negative Tigecycline is designed for antimicrobial susceptibility testing of Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Citrobacter koseri, Enterobacter aerogenes and Serratia marcescens. 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 antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mog/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdifution 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 card. The VITEK 2 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 systems monitor the growth of each well in the card over a defined period of time (up to 18 hours),

#### bioMérieux, Inc.

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

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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.

VITEK 2 Gram Negative Tigecvoline demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined 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 Negative Tigecycline. 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 Negative Tigecycline by comparing its performance with the CLSI (formerly NCCLS) agar dilution reference method. VITEK 2 Gram Negative Tigecycline demonstrated acceptable performance of 91.9% overall Category Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.

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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 stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The caduceus is depicted with a bird-like figure with three lines representing the wings or body, and the text is in a simple, sans-serif font.

SEP 2 9 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Jolyn Tenllado Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320

Re: k052311

Trade/Device Name: VITEK® 2 Gram Negative Tigecycline (≤0.5 - ≥8 µg/ml) 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: August 23, 2005 Received: August 24, 2005

Dear Ms. 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Spccial 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, Codc 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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#### Page 2 -

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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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). 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, a Hogg

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

k052311 510(k) Number (if known):

Device Name:_________________ VITEK® 2 Gram Negative (≤0.5 - ≥8 µg/ml)

Indications For Use:

VITEK®2 Gram Negative Tigecycline is intended for antimicrobial susceptibility testing of Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Citrobacter koseri, Enterobacter aerogenes, and Serratia marcescens. VITEK 2 Gram Negative Tigecycline is a qualitative test. It is intended for use with the VITEK 2 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 gram-negative bacilli and 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)

Luddi te. Paole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K05 2311