VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE

K113783 · bioMerieux, Inc. · LON · Aug 7, 2012 · Microbiology

Device Facts

• Record ID: K113783
• Device Name: VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Aug 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

VITEK® 2 AST – Gram Positive Penicillin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 AST – Gram Positive Penicillin for Streptococcus pneumoniae is a quantitative test 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. Penicillin has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial. Streptococcus pneumoniae (pneumonia and meningitis)

Device Story

VITEK 2 AST cards are miniaturized versions of the broth microdilution technique for determining minimum inhibitory concentrations (MIC). Input: bacterial isolate diluted in 0.45-0.5% saline. Operation: card rehydrated with sample; VITEK 2 system automatically fills, seals, and incubates; VITEK 2 Compact uses manual filling/sealing. System monitors growth in card wells over time. Output: MIC value and interpretive category result. Used in clinical laboratories to guide antimicrobial therapy decisions by identifying susceptibility of S. pneumoniae to penicillin. Benefits: provides automated, standardized susceptibility testing to support clinical treatment choices.

Clinical Evidence

External evaluation conducted using fresh and stock clinical isolates and stock challenge strains. Performance compared against CLSI broth microdilution reference method. Results showed 92.3% Category Agreement for pneumonia breakpoints and 96.9% Category Agreement for meningitis breakpoints. Reproducibility and Quality Control testing yielded acceptable results.

Technological Characteristics

Miniaturized broth microdilution card format. Sensing principle: optical growth monitoring of wells over time. System: VITEK 2 and VITEK 2 Compact automated platforms. Connectivity: integrated with VITEK 2 system software. Sterilization: not specified.

Indications for Use

Indicated for antimicrobial susceptibility testing of Streptococcus pneumoniae (pneumonia and meningitis) using isolated colonies. Intended for use by laboratory professionals as an aid in determining in vitro susceptibility to antimicrobial agents.

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 Amoxicillin for Streptococcus pneumoniae (K063597)

Submission Summary (Full Text)

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K//3783

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7 2012 AUG

## 510(k) SUMMARY

### VITEK® 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae

#### 510(k) Submission Information:

Submitter's Name:

Address:

bioMérieux, Inc.

919-620-2329

919-620-2548

pneumoniae

December 20, 2011

100 Rodolphe Street Durham, NC 27712

Elizabeth (Betty) Landon Staff Regulatory Affairs Specialist

Phone Number:

Fax Number:

Contact Person:

Date of Preparation:

B. Device Name:

Formal/Trade Name:

Classification Name:

21 CFR 866.1645 Antimicrobial Susceptibility Test Product Code LON

Common Name:

C. Predicate Device:

VITEK® 2 Gram Positive Amoxicillin for Streptococcus pneumoniae (K063597)

VITEK 2 AST-GP Penicillin for Streptococcus pneumoniae

VITEK® 2 AST - Gram Positive Penicillin for Streptococcus

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

VITEK 2 Gram Positive Penicillin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is intended for use with the 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 versons 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 with 0.45 - 0.5% 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, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion 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 Penicillin for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the

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Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued August 28, 2009.

The Premarket Notification (510(k)) presents data in support of VITEK 2 Gram Positive Penicillin for Streptococcus pneumoniae. An external evaluation was conducted with fresh and stock clinical isolat4es and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Penicillin for Streptococcus pneumoniae 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 Penicillin for Streptococcus pneumoniae demonstrated acceptable performance of 92.3% and 96.9% Category Agreement based on the pneumonia and meninatis breakpoints, respectively. 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and well-being.

10903 New Hampshire Avenue Silver Spring, MD 20993

bioMerieux, Inc. c/o Elizabeth Landon 100 Rodolphe Street Durham, NC 27712

AUG 7 2012

k113783 Re:

Trade Name: VITEK® 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae Regulation Number: 21 CFR §866.1645 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Codes: LON Dated: July 24, 2012 Received: July 26, 2012

Dear Ms. Landon:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Uwe. Sick for

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

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## Indications for Use

# 510(k) Number (if known):_ k l(3 7 8 3

Device Name: VITEK® 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae ( ≤ 0.06 -- ≥ 8 µg/mL )

#### Indications For Use:

VITEK® 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae is a quantitative test 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. Penicillin has been shown to be active against most strains of the microorqanism listed below, according to the FDA label for this antimicrobial.

Streptococcus pneumoniae (pneumonia and meningitis)

· 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, 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)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Leesdale Poole

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k113783

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