MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN

K051311 · Dade Behring, Inc. · LON · Jul 12, 2005 · Microbiology

Device Facts

• Record ID: K051311
• Device Name: MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN
• Applicant: Dade Behring, Inc.
• Product Code: LON · Microbiology
• Decision Date: Jul 12, 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℃ +/- 1℃, in a WalkAway® SZ, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert. This particular submission is for the addition of the antimicrobial Levofloxacin, at concentrations of 0.03 to 16 ug/ml, to the test panel.

Device Story

MicroScan® Synergies plus™ panels are diagnostic tools for antimicrobial susceptibility testing (AST). Panels contain dehydrated antibiotics and control wells; rehydrated with bacterial suspension (turbidity method). System uses WalkAway®-SI instrument with colorimetric optics (lamp/photosensor) to monitor bacterial growth. Device measures growth kinetics to determine Minimum Inhibitory Concentration (MIC) at 4.5–16 hours or via overnight incubation (16–20 hours). Output is quantitative MIC and qualitative susceptibility interpretation. Used in clinical microbiology laboratories by technicians. Results assist clinicians in selecting appropriate antibiotic therapy for gram-positive infections.

Clinical Evidence

Bench testing only. Performance evaluated using fresh clinical isolates and stock challenge strains compared to a frozen reference panel. Essential Agreement for Levofloxacin was >98%. Reproducibility and precision were confirmed using the WalkAway® system and turbidity inoculum preparation. Quality control testing met acceptable standards.

Technological Characteristics

Miniaturized broth dilution susceptibility test; dehydrated antimicrobial agents in microtiter wells. Rehydrated with Pos Broth. Incubation 4.5-18 hours at 35°C. Compatible with WalkAway® instrumentation or visual reading. Connectivity via automated instrument interface.

Indications for Use

Indicated for testing levofloxacin (0.03–16 µg/mL) against Enterococcus and Staphylococcus species in gram-positive test panels. Requires 4.5–16 hours or 16–20 hours incubation. For prescription use only; turbidity method of inoculum preparation required.

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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K0513//

## JUL 1 2 2005

## 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 - Levofloxacin |
| Predicate device: | MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels and<br>MicroScan® Dried Gram-Positive Panels |

### 510(k) Summary:

) Sunlimal y .
MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid MICrossen Sylerges pras Grain Fosteright Antimicrobial Susceptibility Testing (AST) technologies, r labogethe 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 I he antinued in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute been untiled in watch and delythated. Various untilisers of clinical interest. Panels are rehydrated with Synergies plus" Pos Broth, after inoculation with a standardized suspension of the organism. After Syllergics pus - 1 03 Droum, and movement, for 4.5 - 18 hours, the minimum inhibitory meddation in the wants thays of by determining the lowest antimicrobial concentration showing inhibition of growth.

The proposed MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel demonstrated substantially TIE proposed Microbean "Official Prace Reference Panel, as defined in the FDA document equivalent performance Midance Document: Antimicrobial Susceptibility Test (AST) Systems; Class II Special Controls Guidiner Document y 5, 2003. The Premarket Notification (510[k]) presents Outdates for madely and I Dr. , as were gies plus" Gram-Positive MIC/Combo Panel with Levofloxacin.

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-The external evaluations were performance with a frozen Reference panel. Challenge strains were Fositive Faller by companing is performation. The Synergies plus " Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of >98% for Levofloxacin when compared with the frozen Reference panel.

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

Quality Control testing demonstrated acceptable results for Levofloxacin.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 2 2005

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

Re: k051311 Trade/Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Levofloxacin (0.03 - 16 ug/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, JWY, LRG, LTT, LTW Dated: May 13, 2005 Received: May 24, 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,

Sales, 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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# Indications for Use

510(k) Number (if known):

Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Levofloxacin (0.03-16 ug/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℃ +/- 1℃, in a WalkAway® SZ, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Levofloxacin, at concentrations of 0.03 to 16 ug/ml, to the test panel.

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

> Enterococcus faecalis Staphylococcus aureus (methicillin-susceptible strains) Staphylococcus epidermidis (methicillin-susceptible strains) Staphylococcus saprophyticus Staphylococcus haemolyticus

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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