VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE

K050976 · bioMerieux, Inc. · LON · May 23, 2005 · Microbiology

Device Facts

• Record ID: K050976
• Device Name: VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: May 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2
• Attributes: AI/ML

AI Performance

Output	Acceptance	Observed	Dev DS	Test DS
Trimethoprim/sulfamethoxazole susceptibility for Staphylococcus aureus	Category agreement (CA) acceptable when compared to the reference method as described in the FDA guidance document, 'Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems'.	Combined Category Agreement (CA) of 99.6% (478/480).	Not specified.	Clinical study: 405 clinical isolates tested at three sites. Challenge study: 75 isolates tested at one site.

Intended 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 susceptibility testing of isolated colonies of clinically significant aerobic gram-positive bacteria, including Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. VITEK® 2 Gram Positive Trimethoprim/sulfamethoxazole is designed for susceptibility testing of Staphylococcus aureus. VITEK 2 Gram Positive Trimethoprim/sulfamethoxazole is a qualitative test. 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.

Device Story

VITEK® 2 Gram Positive Trimethoprim/sulfamethoxazole card is an in vitro diagnostic test for antimicrobial susceptibility. Input: pure culture organism suspension standardized to McFarland 0.5. Operation: card contains 64 microwells with premeasured antibiotic and culture medium; system automatically fills/seals (or manual for Compact) and incubates at 35.5°C. Optical scanning monitors growth via light transmittance every 15 minutes for up to 18 hours. Output: MIC value and interpretive category result. Used in clinical laboratories by technicians/lab staff. Results assist healthcare providers in determining appropriate antimicrobial therapy for Staphylococcus aureus infections.

Clinical Evidence

Bench testing only. Performance evaluated using fresh and stock clinical isolates and challenge strains. Compared against NCCLS reference macrobroth dilution method. Results demonstrated 99.6% overall Category Agreement. Reproducibility and Quality Control testing yielded acceptable results.

Technological Characteristics

Microdilution-based AST card with 64 microwells. Uses optical transmittance to measure organism growth. Automated incubation at 35.5°C. Compatible with VITEK® 2 and VITEK® 2 Compact systems. Software-based discriminant analysis algorithm for MIC calculation.

Indications for Use

Indicated for testing Staphylococcus aureus susceptibility to Trimethoprim/sulfamethoxazole (concentrations 2, 8, 16 ug/mL; calling range ≤0.5/9.5-≥16/304 ug/mL) using VITEK® 2 and VITEK® 2 Compact Systems. 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 Gram Positive AST Panel for sparfloxacin (N50510/S141)

Submission Summary (Full Text)

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K050976

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MAY 2 3 2005

## VITEK® 2 Gram Positive Trimethoprim/sulfamethoxazole

### 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: | April 12, 2005 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Trimethoprim/sulfamethoxazole |
| Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device, 21 CFR 866.1645 |
| Common Name: | VITEK 2 AST-GP SXT |
| Prodicate Device: | VITEK 2 Gram Positive AST for Sparfloxacin |

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

C. Predicate Device:

B.

VITEK® 2 Gram Positive Trimethoprim/sulfamethoxazole is designed for antimicrobial susceptbility VITER 2 Oran't oolare himourophin since with the VITEK® 2 and 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 r he unlinerebial procentrations in mcg/mi. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

(N50510/S141)

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 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 Trimethoprim/sulfamethoxazole demonstrated substantially equivalent performance when compared with the NCCLS reference macrobroth 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.

800/638-4835 Fax: 314/731-Phone: [phone] Anglum Road, Hazelwood, Missouri 63042-2320, USA 8700

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The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive The Premiation (o ro[it]) procente levaluation was conducted with fresh and stock Trined isolates and stock challenge strains. The external evaluations were designed to confirm the cillitical solates and stock onailer Trimethoprim/ suffamethoxazole by comparing its acceptablily of VTLR 2 Oran Positive minorition reference method. The data is representative of performance with the NOOLS macrosition relevel instrument platforms, as evidenced in the periormance on bout the VTTEK 2 and VTER 2 Compact file, K050002 . VITEK 2 Gram Positive AST equivalency study presented in the VITER a Company of 99.6% overall Category Agreement. 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 3 2005

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

k050976 Re:

K02070
Trade/Device Name: VITEK® 2 Gram Positive Trimethoprim/Sulfamethoxazole (< 0.5/9.5 - ≥ 16/304 µg/mlT 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: April 12, 2005 Received: April 18, 2005

Dear Ms. Weaver:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your bector of the device is substantially equivalent (for the indications felerenced above and nave determined a vices and and one ices marketed in interstate for use stated in the encreate) to regarry the enactment date of the Medical Device Amendments, or to contineree prior to May 20, 1978, the encordance with the provisions of the Federal Food, DINE, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosmette Act (110) that do noves, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the device, equirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is Classified (300 a00 v) incl. Existing major regulations affecting your device it may be subject to such additional democrations (CFR), Parts 800 to 895. In addition, FDA can be found in The 21, Occareents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri s issuated of a bustical with other requirements of the Act that FDA has made a decemination administered by other Federal agencies. You must of any Federal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, into and 809); and good manufacturing practice CFR Part 807), labeling (21 CF RT 11 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) I his letter whi anow you to ocgin manceang your and equivalence of your device to a legally prematication. "The I DTV intentig gour device and thus, permits 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, of k If you desire specific information as advertising of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the Viro Diagnostic Device Device Liver and to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the 1 ou may of and 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,

Sales, a Form

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): \$05097 (e

Device Name: VITEK® 2 Gram Positive Trimethoprim/sulfamethoxazole (< 0.5/9.5 – ≥ 16/304 µg/ml)

Indications For Use:

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the The VTER 2 Antimioronal Systems for the automated quantitative or qualitative or qualitative or qualitative or qualitative or qualitative or qualitative or chiliante or VITER 2 and VTTEN 2 Oompact Uyically significally significant aerobic gramsusceptibility testing of isolatou contrile in the more of streptococcus agalactiae, and S. pneumoniae.

S. priedmoniae.
VITEK® 2 Gram Positive Trimethoprim/sulfamethoxazole is designed for Trimethoprim VITEK 2 Gram Postive Thinethophiniounciller. VITEK 2 Gram Positive Trimethopim/
susceptibility testing of Staphylococcus aureus. VITEK 2 Gram Positive NITEK 2 only!TE Susceptiblity testing of Oraphyloooous and out of the VITEK 2 and VITEK 2 and VITEK
sulfamethoxazole is a qualitative test. It is intended for use with the virus and VITEK Sullamethoxazole is a qualitative tocain 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)

Luddi L. Pool
Division Sign-Off

# Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

p. 10

K650976 510(k)________________________________________________________________________________________________________________________________________________________________________