MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML)

K053504 · Dade Behring, Inc. · LON · Feb 24, 2006 · Microbiology

Device Facts

• Record ID: K053504
• Device Name: MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML)
• Applicant: Dade Behring, Inc.
• Product Code: LON · Microbiology
• Decision Date: Feb 24, 2006
• 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 Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert. This particular submission is for the addition of the antimicrobial Erythromycin, at concentrations of 0.12 to 16 ug/ml, 0.5-4 ug/ml and 0.5-1, 4 ug/ml for Staphylococci, to the test panel. The gram-positive organisms which may be used for Erythromycin susceptibility testing in this panel are: Staphylococcus aureus

Device Story

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels perform antimicrobial susceptibility testing (AST) on gram-positive bacteria. Panels contain dehydrated antimicrobial agents; rehydrated with Synergies plus™ Pos Broth after inoculation with standardized organism suspension. Incubation occurs in WalkAway® SI system (or equivalent) for 4.5–18 hours; alternatively, non-CO2 incubation with visual reading. Device determines minimum inhibitory concentration (MIC) by identifying lowest antimicrobial concentration inhibiting growth. Used in clinical microbiology laboratories by trained technicians. Output provides quantitative/qualitative susceptibility data; assists clinicians in selecting appropriate antibiotic therapy for patients with staphylococcal or enterococcal infections.

Clinical Evidence

Bench testing only. Performance evaluated using 301 fresh and 75 challenge Staphylococci spp. isolates. Compared against CLSI reference broth dilution method. Rapid instrument read (4.5–16h) showed 96.8% Essential Agreement (EA) and 97.6% Category Agreement (CA). Overnight instrument read showed 99.7% EA and 99.5% CA. Overnight manual read showed 100% EA and 100% CA. Reproducibility >95% across all methods. No growth rate <10%.

Technological Characteristics

Microdilution panels; dehydrated antimicrobial agents in water/buffer/broth. Sensing via rapid fluorogenic identification and AST. Incubation 4.5-18 hours at 35°C. Compatible with WalkAway® SI automated system or manual visual reading. Connectivity via automated instrument interface.

Indications for Use

Indicated for testing Staphylococcus spp. using erythromycin (0.12–16 µg/mL, 3-dilution, or 4-dilution BP sequences) at 4.5–16 hours or 16–20 hours (overnight). Prescription use only. Turbidity method 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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-EB 2 4 2006

K053504

510(k) Submission Information: Device Manufacturer: Dade Behring Inc. Contact name: Robert Eusebio, Regulatory Affairs Manager 916-374-3144 Fax: Date prepared: August 22, 2005 Product Name: Microdilution Minimum Inhibitory Concentration (MIC) Panels MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels Trade Name: To determine antimicrobial agent susceptibility Intended Use: New antimicrobia1 - Erythromycin 510(k) Notification: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Predicate device: Panels and 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 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 Synergies plus™ Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI, or equivalent, 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 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 Erythromycin.

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

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Agreement of 96.8% for Erythromycin when compared with the frozen Reference panel.

Instrument reproducibility testing demonstrated acceptable reproducibility and mstrainent reproductions) with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent.

Quality Control testing demonstrated acceptable results for Erythromycin.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the wings and body. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## FEB 2 4 2006

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

Re: k053504

Trade/Device Name: MicroScan® Synergies plus ™ Gram-Positive MIC/Combo Panels Erythromycin (0.12 - 16 µg/ml, 0.5-4 µg/ml and 0.5-1, 4 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system. Regulatory Class: Class II Product Code: LON, LRG, JWY, LTT Dated: December 16, 2006 Received: January 9, 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 for and barned in 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 or any 1 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,

Sally, a story

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): K053504_

Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Erythromycin (0.12 - 16 ug/ml, 0.5-4 ug/ml and 0.5-1, 4 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 Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Erythromycin, at concentrations of 0.12 to 16 ug/ml, 0.5-4 ug/ml and 0.5-1, 4 ug/ml for Staphylococci, to the test panel.

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

Staphylococcus aureus

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

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

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