VITEK 2 GRAM POSITIVE TIGECYCLINE

K072695 · bioMerieux, Inc. · LON · Nov 16, 2007 · Microbiology

Device Facts

• Record ID: K072695
• Device Name: VITEK 2 GRAM POSITIVE TIGECYCLINE
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Nov 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2
• Attributes: AI/ML

AI Performance

Output	Acceptance	Observed	Dev DS	Test DS
Antimicrobial Susceptibility Testing (Tigecycline)	Category Agreement (CA) ≥ 90% (implied standard for AST systems)	Combined Category Agreement (CA) of 99.4% for the automated dilution method.	Not specified (Algorithm developed using discriminate analysis).	External evaluation at 3 clinical sites including 862 clinical isolates (280 fresh) and a challenge set of 105 organisms.

Intended Use

VITEK® 2 Gram Positive Tigecycline 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 Tigecycline is a qualitative test. Tigecycline has been shown to be active against the organisms listed below according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Enterococcus faecalis (Vancomycin-susceptible isolates only) Staphylococcus aureus (methicillin-susceptible and -resistant isolates) Streptococcus agalactiae Active in vitro but their clinical significance is unknown: Enterococcus faecium (Vancomycin susceptible and resistant isolates) Staphylococcus epidermidis Staphylococcus haemolyticus Enterococcus casseliflavus. 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 Gram Positive Tigecycline card is an in vitro diagnostic test for antimicrobial susceptibility. Input: bacterial suspension from pure culture, standardized to McFarland 0.5 using DensiChek turbidity meter. Operation: card contains 64 microwells with pre-measured antibiotic and culture medium; instrument performs automated vacuum filling, sealing, and incubation at 35.5°C. Principle: optics system measures light transmittance every 15 minutes to detect organism growth; growth inhibition indicates susceptibility. Output: quantitative MIC and categorical interpretation (susceptible/non-susceptible). Used in clinical laboratories by technicians. Results assist healthcare providers in determining antimicrobial susceptibility for specific gram-positive organisms. Benefits: automated, rapid determination of MIC compared to manual broth microdilution.

Clinical Evidence

Bench testing only. External evaluation conducted using fresh and stock clinical isolates and stock challenge strains. Performance compared against CLSI broth microdilution reference method. Results demonstrated 99.4% overall Category Agreement. Reproducibility and Quality Control testing yielded acceptable results.

Technological Characteristics

Polystyrene test card with 64 microwells containing pre-measured antibiotic and culture medium. Sensing principle: transmittance optics (visible light) measuring growth inhibition. Energy source: VITEK® 2 instrument (incubation/optics). Connectivity: VITEK® 2/VITEK® 2 Compact system. Software: automated growth detection algorithm using discriminate analysis. Sterilization: not specified.

Indications for Use

Indicated for use as a laboratory aid in determining in vitro susceptibility to tigecycline (0.25, 0.5, 1.0 µg/ml) for Enterococcus faecalis (vancomycin-susceptible), Staphylococcus aureus (methicillin-susceptible and -resistant), Streptococcus agalactiae, Enterococcus faecium (vancomycin-susceptible and -resistant), Staphylococcus epidermidis, Staphylococcus haemolyticus, and Enterococcus casseliflavus. Not for direct clinical specimens or mixed flora. 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 (K050075)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for bioMerieux on the left side of the image. To the right of the logo is the number K072695. The logo consists of a circle with lines inside of it and the name of the company below it. The number is handwritten and appears to be a serial number.

### 510(k) SUMMARY

## VITEK® 2 Gram Positive Tigecycline

N 1 6 2007

#### 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: | September 20, 2007 |
| <b>B. Device Name:</b> | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Tigecycline ( $≤$ 0.12 - $≥$ 2 µg/ml) |
| Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device, 21 CFR 866.1645 |
| Common Name: | VITEK 2 AST-GP Tigecycline |
| C. Predicate Device: | VITEK 2 Gram Positive Daptomycin (K050075). |

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

B. D

VITEK® 2 Gram Positive Tigecycline 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 Tigecycline is a qualitative test. Tigecycline has been shown to be active against the organisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections: Enterococcus faecalis (Vancomycin-susceptible isolates only) Staphylococcus aureus (methicillin-susceptible and -resistant isolates) Streptococcus agalactiae

Active in vitro but their clinical significance is unknown: Enterococcus faecium (Vancomycin susceptible and resistant isolates) Staphylococcus epidermidis Staphylococcus haemolyticus Enterococcus casseliflavus.

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

#### bioMérieux, Inc.

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

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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 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 MC value along with the interpretive category result for each antibiotic contained on the card.

VITEK 2 Gram Positive Tigecycline 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 Feb. 5, 2003.*

The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive 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 Positive Tigecycline by comparing its performance with the CLSI broth microdilution 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 Tigecycline demonstrated acceptable performance of 99.4% 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 quidance document is cited.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.

NOV 1 6 2007

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Jolyn Tellando Senior Regulatory Affairs Specialist bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042

Re: k072695

Trade/Device Name: VITEK® 2 Gram Positive Tigecycline (≤ 0.12 -> 2 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Short term Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LON Dated: September 20, 2007 Received: September 24, 2007

Dear Ms. Tellando:

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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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 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): K072695

Device Name: VITEK® 2 Gram Positive Tigecycline (< 0.12 - > 2 µg/ml)

Indications For Use:

VITEK® 2 Gram Positive Tigecycline 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 Tigecycline is a qualitative test. Tigecycline has been shown to be active against the organisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections:

Enterococcus faecalis (Vancomycin-susceptible isolates only) Staphylococcus aureus (methicillin-susceptible and -resistant isolates) Streptococcus agalactiae

Active in vitro but their clinical significance is unknown: Enterococcus faecium (Vancomycin susceptible and resistant isolates) Staphylococcus epidermidis Staphylococcus haemolyticus Enterococcus casseliflavus.

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 (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)

Concerrence of CORH, Office of In Vitro Diagnostic Devices (OIVD) Fleddle est

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K072695

K072695, Amended p. 9