SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS

K051350 · Dade Behring, Inc. · LON · Jul 25, 2005 · Microbiology

Device Facts

• Record ID: K051350
• Device Name: SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
• Applicant: Dade Behring, Inc.
• Product Code: LON · Microbiology
• Decision Date: Jul 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the AST portions can be read visually, according to the Package Insert.

Device Story

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels are used for antimicrobial susceptibility testing (AST) of gram-positive cocci and Listeria. The device utilizes dehydrated antibiotic panels rehydrated with an inoculated broth suspension (turbidity method). The WalkAway®-SI system uses a colorimetric optics system (color wheel/lamp assembly and photosensor) to detect bacterial growth by measuring optical changes over time. The system performs periodic readings starting at 4.5 hours up to 16 hours for rapid results, or 16-20 hours for overnight results. The device provides quantitative MIC values and qualitative interpretations. It is intended for use in clinical laboratories by trained personnel. The output assists clinicians in selecting appropriate antimicrobial therapy for patients with bacterial infections.

Clinical Evidence

Bench testing only. Performance evaluated using fresh and stock clinical isolates and challenge strains. Compared against CLSI frozen reference panels. Essential Agreement for Trimethoprim/Sulfamethoxazole was >98%. Reproducibility and precision were confirmed using the WalkAway® System and turbidity inoculum preparation. Quality control testing met acceptable criteria.

Technological Characteristics

Miniaturized broth dilution panels; dehydrated antimicrobial agents in wells. Rehydrated with Synergies plus™ Pos Broth. Incubation at 35°C +/- 1°C. Compatible with WalkAway® SI automated instrumentation or visual reading. Utilizes rapid fluorogenic identification and dried overnight antimicrobial susceptibility testing technologies.

Indications for Use

Indicated for testing of Staphylococcus spp. with Trimethoprim/Sulfamethoxazole at concentrations between 0.5/9.5 to 8/152 µg/mL on gram-positive test panels for testing at 4.5-16 hours or 16-20 hours for overnight reading.

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

• MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels
• MicroScan® Dried Gram-Positive Panels

Submission Summary (Full Text)

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K05-1350

## JUL 25 2005

Page 1 of ___

## 510(k) Summary

#### 510(k) Submission Information:

| Device Manufacturer: | Dade Behring Inc. |
|----------------------|--------------------------------------------------------------------------|
| Contact name: | Robert Eusebio, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | April 25, 2005 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Trimethoprim/Sulfamethoxazole |
| Predicate device: | MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels and MicroScan® |
| | Dried Gram-Positive Panels |

#### 510(k) Summarv:

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptbility Testing (AST) technologies, are designed for use in determining quantitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci and enterococci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute concentrations of broth, to concentrations bridging the range of clinical interest. Panels are rehydrated with Synergies plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI System, or equivalent, for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

The proposed MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with a CLSI frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA', dated February 5, 2003. The Premarket Notification (510/k]) presents data in support of the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel with Trimethoprim/Sulfamethoxazole.

The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Synergies plus " Gram-Positive Panel by comparing its performance with a frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The Synergies plus" Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of >98% for Trimethoprim/Sulfamethoxazole when compared with the frozen Reference panel.

Instrument reproducibility testing demonstrated acceptable reproducibility and precision for Trimethoprim/Sulfamethoxazole, with Turbidity inoculum preparation method and the WalkAway® System or equivalent.

Quality Control testing demonstrated acceptable results for Trimethoprim/Sulfamethoxazole.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the 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 an eagle with its wings spread.

JUL 25 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Robert Eusebio Regulatory Affairs Manager Dade Behring 1584 Enterprise Boulevard West Sacramento, CA 95691-9972

Re: k051350

Trade/Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels Trimethoprim/Sulfamethoxazole (0.5/9.5-8/152 µg/ml) Regulation Number: 21 CFR 866.1645, 866.1640 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system. Regulatory Class: Class II Product Code: LON, JWY, LRG, LTT Dated: May 19, 2005 Received: June 1, 2005

Dear Mr. Eusebio:

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), 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 Hory

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):

Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Trimethoprim/Sulfamethoxazole (0.5/9.5-8/152 µg/ml)

> Indications For Use: The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the AST portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial agent Trimethoprim/Sulfamethoxazole, at concentrations of 0.5/9.5 to 8/152 ug/ml, to the test panel.

The gram-positive organisms which may be used for Trimethoprim/Sulfamethoxazole susceptibility testing in this panel are:

> Staphylococcus aureus Staphylococcus epidermidis Staphylococcus species - Coagulase Negative Staphylococcus saprophyticus

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)

Concurrent Six Sich Significan In Vitto Diagno Devices (OIVD)

T S 510k a.doc 5/20/2005

Office of In Vitro Diagnostic Device Evaluation and Safety

ko 51350 510(k).

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