VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE

K051849 · bioMerieux, Inc. · LON · Aug 16, 2005 · Microbiology

Device Facts

• Record ID: K051849
• Device Name: VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Aug 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

The VITEK®2 Antimicrobial Susceptibility Test is intended to be used with the VITEK®2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. The VITEK®2 Gram Positive Susceptibility Card is intended for use with the VITEK®2 system in clinical laboratories as an in vitro test to determine the susceptibility of Streptococcus pneumoniae to antimicrobial agents when used as instructed in the Online Product Information.

Device Story

VITEK®2 system performs automated antimicrobial susceptibility testing (AST) on isolated colonies. Device uses 64-microwell cards containing premeasured antibiotics and culture medium. Organism suspension (McFarland 0.5) is prepared manually or automatically, vacuum-filled into cards, and sealed. Instrument incubates cards at 35.5°C while performing optical scanning every 15 minutes. Transmittance optics measure organism growth by monitoring light blockage. Discriminate analysis algorithm processes growth characteristics to calculate MIC and determine category interpretation (S, I, R). Results assist clinicians in selecting appropriate antibiotic therapy for S. pneumoniae infections.

Clinical Evidence

External evaluation conducted using fresh and stock clinical isolates and stock challenge strains. Performance compared against CLSI (NCCLS) microbroth dilution reference method. Results demonstrated 94.9% overall Category Agreement. Reproducibility and Quality Control testing yielded acceptable results.

Technological Characteristics

Miniaturized AST card containing antimicrobial medium. Sensing principle: optical monitoring of bacterial growth in wells over 18 hours. Connectivity: integrated with VITEK 2 and VITEK 2 Compact instrument platforms. Software-based automated analysis of growth kinetics to determine MIC.

Indications for Use

Indicated for antimicrobial susceptibility testing of Streptococcus pneumoniae isolates. Intended for use in clinical laboratory settings to determine 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 Susceptibility Card for Gatifloxacin (k032314)

Submission Summary (Full Text)

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BIOMÉRIEUX

K051849

## 510(k) SUMMARY

AUG 1 6 2005

# VITEK® 2 Gram Positive Ertapenem for Streptococcus pneumoniae

### 510(k) Submission Information:

| | Submitter's Name: | bioMérieux, Inc. |
|-----------------|----------------------|-----------------------------------------------------------------------------------------------------|
| | Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| | Contact Person: | Nancy Weaver<br>Staff Regulatory Affairs Specialist |
| | Phone Number: | 314 -731-8695 |
| | Fax Number: | 314-731-8689 |
| | Date of Preparation: | July 6, 2005 |
| B. Device Name: | | |
| | Formal/Trade Name: | VITEK® 2 Gram Positive Ertapenem for Streptococcus<br>pneumoniae |
| | Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device, 21 CFR 866.1645 |
| | Common Name: | VITEK 2 AST-GP ETP |
| | C. Predicate Device: | VITEK 2 Gram Positive Moxifloxacin for Streptococcus<br>pneumoniae (K031865). |

### D. 510(k) Summary:

B.

VITEK® 2 Gram Positive Ertapenem for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. 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 (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 MIC value along with the interpretive category result for each antibiotic contained on the card.

VITEK 2 Gram Positive Ertapenem for Streptocccus pneumoniae demonstrated substantially equivalent performance when compared with the CLSI (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.

#### bioMérieux, Inc.

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

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The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Ertapenem for Streptococcus pneumoniae. 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 Ertapenem for Streptococcus pneumoniae by comparing its performance with the CLSI (NCCLS) microbroth dilution reference method. The data is representative of performance on both the VITEK 2 System 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 Ertapenem for Streptococcus pneumoniae demonstrated acceptable performance of 94.9% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.

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AUG 1 6 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nancy Weaver Staff Regulatory Affairs Specialist bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320

k051849 Re: Trade/Device Name: VITEK 20 Gram Positive Ertapenem for Streptococcus pneumoniae (≤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: July 6, 2005 Received: July 7, 2005

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 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" (21CFR 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,

Sale, a 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

Enclosure

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510(k) Number (if known): K051849

Device Name: VITEK® 2 Gram Positive Ertapenem for Streptococcus pneumoniae (< 0.5 - > 8 µg/ml)

Indications For Use:

. .

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 viren = and virier = oompact lonies for the most clinically significant aerobic gramsusceptiblicy toculing of hocaccus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

O: phounder. vilier 2 Gram . Streptococcus pneumoniae. VITEK 2 Gram anniniorobial odoopilland use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

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)

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KO 51849 510(k) _______________________________________________________________________________________________________________________________________________________________________