VITEK 2 STREPTOCOCCUS PENICILLIN

K112000 · bioMerieux, Inc. · LON · Oct 26, 2011 · Microbiology

Device Facts

• Record ID: K112000
• Device Name: VITEK 2 STREPTOCOCCUS PENICILLIN
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Oct 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

VITEK® 2 Streptococcus Penicillin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Penicillin 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. Active In Vitro and in Clinical Infections against: Beta hemolytic streptococci groups C and G Streptococcus pyogenes Streptococcus agalactiae Streptococcus viridans group Streptococcus pneumoniae 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 bacili, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

Device Story

VITEK® 2 Streptococcus Penicillin is an in vitro diagnostic test card used with VITEK® 2 and VITEK® 2 Compact Systems. It performs automated quantitative susceptibility testing of isolated Streptococcus colonies against Penicillin. The system processes samples to determine minimum inhibitory concentrations (MICs). Used in clinical microbiology laboratories by trained technicians/microbiologists. Output provides quantitative susceptibility data to assist clinicians in selecting appropriate antimicrobial therapy for patients with streptococcal infections.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing comparing the VITEK® 2 AST-ST Penicillin performance against reference methods for determining antimicrobial susceptibility.

Technological Characteristics

The device consists of a test card containing specific concentrations of Penicillin (≤ 0.06 - ≥ 8 ug/mL). It utilizes the VITEK® 2 system's automated optical growth monitoring technology. The system is a closed, automated platform for quantitative susceptibility testing. No specific materials or software architecture details provided beyond system compatibility.

Indications for Use

Indicated for antimicrobial susceptibility testing of Streptococcus species (Beta hemolytic groups C/G, S. pyogenes, S. agalactiae, S. viridans, S. pneumoniae) in patients requiring in vitro susceptibility determination to Penicillin. For 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 AST-GP Amoxicillin for S. pneumoniae (K063597)

Submission Summary (Full Text)

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K1/2000

OCT 2 6 2011

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## 510(k) SUMMARY

### VITEK® 2 AST-ST Penicillin

### 510(k) Submission Information:

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|--------------------------------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Jolyn Tenllado<br>Director, Regulatory Affairs |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | July 12th, 2011 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Streptococcus Penicillin |
| Classification Name: | 21 CFR 866.1645<br>Antimicrobial Susceptibility Test<br>Product Code LON |
| Common Name: | VITEK® 2 AST-ST Penicillin |
| C. Predicate Device: | VITEK® 2 AST-GP Amoxicillin for S. pneumoniae (K063597) |

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

VITEK® 2 Streptococcus Penicilin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Penicillin 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.

#### Active In Vitro and in Clinical Infections against:

Beta hemolytic streptococci groups C and G Streptococcus pyogenes Streptococcus agalactiae Streptococcus viridans group Streptococcus pneumoniae

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 bacili, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

#### bioMérieux, Inc. 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: [phone] Fax: [phone] http://www.biomerieux-usa.com Page 256

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10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 2 6 2011

bioMérieux, Inc. c/o Jolyn Tenllado Director, Regulatory Affairs 595 Anglum Road Hazelwood, Missouri 63042-2320

Re: K112000

Trade/Device Name: VITEK® 2 Streptococcus Penicillin (≤ 0.06 - ≥ 8 ug/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: short-term Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: LON Dated: October 19, 2011 Received: October 20, 2011

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 class II (Special Controls), 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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 - Jolyn Tenllado

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 Parts 801 and 809), 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 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 [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally A. Torgon

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):_KI | 2000

Device Name: VITEK® 2 Streptococcus Penicillin (≤ 0.06 - ≥ 8 ug/mL)

Indications For Use:

VITEK® 2 Streptococcus Penicillin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Penicillin 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.

Active In Vitro and in Clinical Infections against:

Beta hemolytic streptococci groups C and G Streptococcus pyogenes Streptococcus agalactiae Streptococcus viridans group Streptococcus pneumoniae

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System 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 spp. and clinically significant yeast.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

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)

Freddie Lee Poole
Division Sign Off

Avision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K11 9800

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