VITEK 2 GRAM NEGATIVE PIPERACILLIN

K073083 · bioMerieux, Inc. · LON · Dec 10, 2007 · Microbiology

Device Facts

• Record ID: K073083
• Device Name: VITEK 2 GRAM NEGATIVE PIPERACILLIN
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Dec 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

VITEK® 2 Gram Negative Piperacillin is designed for antimicrobial susceptibility testing of gramnegative organisms 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 Negative Piperacillin is a quantitative test. Piperacillin has been shown to be active against most strains of the organisms listed below according to the FDA label for the antirocrobial. Active in vitro and in clinical infections Acinetobacter species Enterobacter species Escherichia coli Klebsiella species Morganella morganii Providencia rettgeri Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia species Active in vitro but their clinical significance is uknown: Burkholderia cepacia Citrobacter koseri (formerly C. diversus) Citrobacter freundii Pseudomonas fluorescens 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 bacilii, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

Device Story

VITEK 2 AST-GN Piperacillin is a miniaturized, automated version of the broth microdilution method for determining minimum inhibitory concentrations (MIC) of piperacillin. The device uses disposable cards containing antimicrobial medium. Clinical laboratory technicians prepare bacterial isolates in 0.45% saline, which are used to rehydrate the card. The VITEK 2 system automatically fills and seals the card; the VITEK 2 Compact system requires manual filling/sealing. The system incubates the card and monitors bacterial growth in each well for up to 18 hours. The system generates a report containing the MIC value and interpretive category. This aids clinicians in selecting appropriate antimicrobial therapy for patients with gram-negative infections.

Clinical Evidence

Performance evaluated via external studies using fresh and stock clinical isolates and challenge strains. Compared against CLSI broth microdilution reference method. Results demonstrated 94.6% Essential Agreement and 92.4% Category Agreement. Reproducibility and quality control testing were acceptable.

Technological Characteristics

Miniaturized broth microdilution card; automated incubation and optical growth monitoring; quantitative MIC determination; compatible with VITEK 2 and VITEK 2 Compact systems.

Indications for Use

Indicated for antimicrobial susceptibility testing of aerobic gram-negative bacilli (Acinetobacter sp., Enterobacter sp., E. coli, Klebsiella sp., M. morganii, P. rettgeri, P. mirabilis, P. vulgaris, P. aeruginosa, Serratia sp., B. cepacia, C. koseri, C. freundii, P. fluorescens) isolated from clinical specimens.

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 Levofloxacin (K072038)

Reference Devices

• VITEK 2 Compact (K050002)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of the company name in a stylized font, with a unique symbol above it. The symbol is a black circle with a line going through it, creating a visual representation of a biological process or scientific concept.

K073083

### 510(k) SUMMARY

## VITEK® 2 Gram Negative Piperacillin

#### 510(k) Submission Information:

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|-----------------------------------------------------------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Nancy Weaver<br>Associate Director, Regulatory Affairs |
| Phone Number: | 314-731-8695 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | October 30, 2007 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Negative Piperacillin (≤ 4 - ≥ 128 µg/ml) |
| Classification Name: | Fully Automated Short-Term Incubation Cycle Antimicrobial<br>Susceptibility Device, 21 CFR 866.1645 |

| Common Name: | VITEK 2 AST-GN Piperacillin |
|--------------|-----------------------------|
|--------------|-----------------------------|

- C. Predicate Device: VITEK 2 Gram Negative Levofloxacin (K072038).
#### D. 510(k) Summary:

VITEK® 2 Gram Negative Piperacillin is designed for antimicrobial susceptibility testing of Acinetobacter sp., Enterobacter sp., Escherichia coli, Klebsiella sp., Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Pseudomonas aeruginosa, Serratia sp., Burkholderia cepacia, Citrobacter diversus, Citrobacter freundii, and Pseudomonas fluorescens. 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 mcg/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MC) 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 MIC value along with the interpretive category result for each antibiotic contained on the card.

VITEK 2 Gram Negative Piperacillin demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II

#### bioMérieux, Inc.

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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 Piperacillin. 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 Piperacillin 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 Negative Piperacillin demonstrated acceptable performance of 94.6% Essential Agreement and 92.4% 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of an eagle with three lines representing its wings or feathers. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font. The text is arranged around the upper half of the circle, following its curvature.

Re:

Public Health Service

ood and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 0 2007

.

Ms. Nancy Weaver Associate Director, Regulatory Affairs bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042

> k073083 Trade/Device Name: VITEK® 2 Gram Negative Piperacillin (≤ 4 - ≥ 128 µg/ml) Regulation Number: 21 CFR § 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Device Regulatory Class: II Product Code: LON Dated: October 30, 2006 Received: November 1, 2006

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 (OS) 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 attyms

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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# Indication for Use

1073083 510(k) Number (if known):

Device Name: VITEK® 2 Gram Negative Piperacillin (≤ 4 - ≥ 128 µg/ml)

Indication For Use:

VITEK® 2 Gram Negative Piperacillin is designed for antimicrobial susceptibility testing of gramnegative organisms 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 Negative Piperacillin is a quantitative test. Piperacillin has been shown to be active against most strains of the organisms listed below according to the FDA label for the antirocrobial.

Active in vitro and in clinical infections

Acinetobacter species Enterobacter species Escherichia coli Klebsiella species

Morganella morganii Providencia rettgeri Proteus mirabilis Proteus vulgaris

Pseudomonas aeruginosa Serratia species

Active in vitro but their clinical significance is uknown: Burkholderia cepacia Citrobacter koseri (formerly C. diversus)

Citrobacter freundii Pseudomonas fluorescens

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

Prescription Use X (21 CFR Part 801 Subpart D)

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Luddeke. Poole

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K0 73083

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