SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS

K071076 · Dade Behring, Inc. · LON · May 21, 2007 · Microbiology

Device Facts

• Record ID: K071076
• Device Name: SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
• Applicant: Dade Behring, Inc.
• Product Code: LON · Microbiology
• Decision Date: May 21, 2007
• 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 enterococci and staphylococci. 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 Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert. This particular submission is for the addition of the antimicrobial oxacillin, at concentrations of 0.03 to 8 ug/ml Long Dilution Sequence for S. aureus and S. lugdunensis, and 0.03 - 2 ug/ml 7-Dilution MIC Dilution Sequence, and 0.12 -- 2 ug/ml 5-Dilution Breakpoint Sequence, for all Staphylococcus species, to the test panel. The Gram-positive organisms which may be used for oxacillin susceptibility testing in this panel are: Staphylococcus species

Device Story

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels are miniaturized broth dilution susceptibility tests; dehydrated antimicrobial agents in wells rehydrated with Pos Broth after inoculation with standardized organism suspension. Panels incubated 4.5-18 hours in WalkAway® SI instrument or equivalent; MIC determined by identifying lowest antimicrobial concentration inhibiting growth. Used in clinical microbiology laboratories; results interpreted by healthcare providers to guide antimicrobial therapy. Benefits include rapid, standardized quantitative/qualitative susceptibility testing for Gram-positive organisms.

Clinical Evidence

Bench testing only. External validation compared performance of Synergies plus™ Gram-Positive Panel with oxacillin against frozen Reference panels using fresh/stock efficacy isolates and challenge strains. Overall Essential Agreement of 97.1% reported for 7-Dilution Sequence (Staphylococcus species). Reproducibility and precision confirmed using Turbidity inoculum method and WalkAway® SI System.

Technological Characteristics

Miniaturized broth dilution panels; dehydrated antimicrobial agents in wells. Rehydrated with Pos Broth. Incubation 4.5-18 hours at 35°C. Compatible with WalkAway® SI automated instrumentation or visual reading. Oxacillin concentrations: 0.03-8 ug/ml (Long), 0.03-2 ug/ml (7-Dilution), 0.12-2 ug/ml (5-Dilution).

Indications for Use

Indicated for determining antimicrobial susceptibility of rapidly growing aerobic and facultative anaerobic Gram-positive enterococci and staphylococci (specifically Staphylococcus species for oxacillin) isolated from solid media. For prescription use.

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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K07/076

## 510(k) Summary

MAY 2 1 2007

| 510(k) Submission Information: | |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Device Manufacturer: Dade Behring Inc. | |
| Contact name: Robert Eusebio, Regulatory Affairs Manager | |
| Fax: [phone] | |
| Date prepared: | April 10, 2007 |
| 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 agent - oxacillin |
| Predicate device: | MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels and<br>MicroScan® Dried Gram-Positive Panels |

510(k) Summary:

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

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 Synergics plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI, 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 frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Tcst (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 oxacillin.

The external validation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external validations 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 97.1%, for the 7-Dilution Sequence (which includes all Staphylococcus species) when compared with the frozen Reference panel and Expected Results.

Ox 510k.doc 4/12/2007

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

Quality Control testing demonstrated acceptable results for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel with oxacillin.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services Utah. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES UTAH" is arranged in a circular fashion around the bird image.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Robert Eusebio Regulatory Affairs Manager Dade Behring Inc. 2040 Enterprise Boulevard West Sacramento. CA 95691

## MAY 2 1 2007

Re: k071076

> Trade/Device Name: MicroScan® Synergies plus ™ Gram-Positive MIC/Combo Panels with oxacillin (0.03 - 8 ug/ml Long Dilution Sequence, 0.03 - 2 ug/ml 7 Dilution MIC Sequence and 0.12 - 2 ug/ml 5 Dilution Breakpoint Sequence) Regulation Number: 21 CFR § 866.1645 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: LON, LRG, LTT, LWY Dated: April 13, 2007 Received: April 16, 2006

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 (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). 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,

Sally attorn

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): KO U0 7/0

Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with oxacillin (0.03 - 8 ug/ml Long Dilution Sequence, 0.03 - 2 ug/ml 7-Dilution MIC Sequence and 0.12 - 2 ug/ml 5-Dilution Breakpoint Sequence)

## 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 enterococci and staphylococci. 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 Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial oxacillin, at concentrations of 0.03 to 8 ug/ml Long Dilution Sequence for S. aureus and S. lugdunensis, and 0.03 - 2 ug/ml 7-Dilution MIC Dilution Sequence, and 0.12 -- 2 ug/ml 5-Dilution Breakpoint Sequence, for all Staphylococcus species, to the test panel.

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

. Staphylococcus species

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)

Luddie M. Poole

KO71076

Division Sign-Off

510(k)_

Office of In Vitro Diagnostic Device Evaluation and Safety

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Ox 510k.doc 4/12/2007

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