VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE

K031865 · bioMerieux, Inc. · LON · Aug 13, 2003 · Microbiology

Device Facts

• Record ID: K031865
• Device Name: VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Aug 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is intended for use with the VITEK® 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Device Story

VITEK® 2 system performs automated antimicrobial susceptibility testing (AST) on isolated S. pneumoniae colonies. System uses test cards containing 64 microwells with premeasured antibiotic concentrations and culture medium. Organism suspension prepared in saline, standardized via DensiChek, and loaded into VITEK® 2 instrument. Instrument automatically dilutes suspension, fills cards via vacuum, seals them, and transfers to incubator carousel. Optical scanning occurs every 15 minutes at 35.5°C to measure growth via light transmittance. Discriminate analysis algorithm processes growth characteristics to calculate MIC results. Results reported as category interpretation (S, I, R) alongside MIC. Used in clinical laboratories to guide antimicrobial therapy decisions.

Clinical Evidence

Bench testing only. Method comparison study performed at three sites using 517 clinical and challenge S. pneumoniae isolates. Compared against broth dilution reference method (5% lysed horse blood). Combined results showed 99.6% Essential Agreement (EA) and 95% Category Agreement (CA). No very major or major discrepancies observed; 26 minor discrepancies reported. Reproducibility >95% across sites using both auto-dilution and manual inoculation methods.

Technological Characteristics

Miniaturized doubling dilution technique for MIC determination. Automated incubation and optical growth monitoring. System uses 0.45% saline for sample preparation. Software-based analysis of growth kinetics to determine MIC and interpretive categories.

Indications for Use

Indicated for antimicrobial susceptibility testing of Streptococcus pneumoniae isolated colonies to determine in vitro susceptibility to moxifloxacin.

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 Streptococcus pneumoniae Susceptibility Test for Ceftriaxone (N50510/S135)

Submission Summary (Full Text)

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# 510(k) SUMMARY

## VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae

### A. Submitter Information:

| Submitter's Name: | bioMérieux, Inc. |
|-----------------------------|--------------------------------------------------------------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Nancy Weaver, Staff Regulatory<br>Affairs Specialist |
| Phone Number: | 314-731-8695 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | June 6, 2003 |
| <b>B. Device Name:</b> | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Moxifloxacin for<br>Streptococcus pneumoniae |
| Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device,<br>21 CFR 866.1645 |
| Common Name: | VITEK 2 AST-GP Moxifloxacin for Streptococcus<br>pneumoniae |
| <b>C. Predicate Device:</b> | VITEK® 2 Streptococcus pneumoniae<br>Susceptibility Test for Ceftriaxone (N50510/S135) |

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

VITEK 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is intended for use with the VITEK® 2 System 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) my 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 automatically fills, seals and places the card into the incubator/reader. The VITEK 2

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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 Moxifloxacin for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the NCCLS reference microbroth dilution method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; guidance for Industry and FDA. Issued February 5, 2003.

The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Moxifloxacin 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 Moxifloxacin for Streptococcus pneumoniae by companing its performance with the NCCLS microbroth dilution reference method. VITEK 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae demonstrated acceptable performance of 99.6% overall Essential Agreement when compared to the microbroth dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.

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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 caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.

Public Health Service

AUG 1 3 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k031865 Re: Trade/Device Name: VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae (0.25-2 mcg/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: June 6, 2003 Received: June 18, 2003

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 (QS) 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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known):

Device Name: VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae, 0.25 - 2 mcg/ml

Indications for Use:

VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is intended for use with the VITEK® 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Neesa 8/12/03
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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Perscription use -
(Per 21 CFR 801.109)

KO3186 2 510(k)_

Over the - Counter un