SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE

K063365 · Dade Behring, Inc. · LON · Dec 8, 2006 · Microbiology

Device Facts

• Record ID: K063365
• Device Name: SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE
• Applicant: Dade Behring, Inc.
• Product Code: LON · Microbiology
• Decision Date: Dec 8, 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 enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, 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 gentamicin, at concentrations of 0.06 to 32 µg/ml Long Dilution Sequence for staphylococci, to the test panel.

Device Story

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels are miniaturized broth dilution susceptibility tests. Panels contain dehydrated antimicrobial agents; rehydrated with Synergies plus™ Pos Broth after inoculation with standardized organism suspension. Incubated in WalkAway® SI instrument (or equivalent) for 4.5-18 hours. Instrument reads minimum inhibitory concentration (MIC) by identifying lowest concentration inhibiting growth. Used in clinical microbiology laboratories by technicians. Output provides quantitative/qualitative susceptibility data to clinicians for antibiotic selection and treatment optimization.

Clinical Evidence

Clinical study evaluated 301 Gram-positive isolates (267 fresh, 34 stock) and 75 challenge isolates across 3 sites. Primary endpoint was Essential Agreement (EA) and Category Agreement (CA) compared to CLSI reference broth dilution. Rapid read (<16h) method achieved 94.6% EA and 97.0% CA. Overnight instrument read achieved 97.7% EA and 96.7% CA. Reproducibility was >95% across all methods. Two very major (vmj) errors (5%) were observed in the rapid read method, attributed to specific isolate antibiograms rather than systemic failure.

Technological Characteristics

Miniaturized broth dilution susceptibility test; dehydrated antimicrobial agents in panel wells. Rehydrated with Pos Broth. Incubation 4.5-18 hours at 35°C. Automated reading via WalkAway® SI instrument or visual reading. Connectivity via instrument integration. Class II device (Product codes: LON, LRG, JWY, LTT).

Indications for Use

Indicated for determining antimicrobial susceptibility of rapidly growing aerobic and facultative anaerobic Gram-positive enterococci and staphylococci (coagulase-positive and coagulase-negative) isolated from solid media. For 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

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

Submission Summary (Full Text)

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1063365

DEC - 8 2006

## 510(k) Summary

510(k) Submission Information: Device Manufacturer: Dade Behring Inc. Contact name: Robert Eusebio, Regulatory Affairs Manager 916-374-3144 Fax: Date prepared: October 31, 2006 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 - gentamicin Predicate device: MicroScan® Synergies plus™ Gram-Negative MIC/Combo 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 anacrobic 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 Synergies 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 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 gentamicin.

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

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Positive Panel demonstrated acceptable performance with an overall Essential Agreement of 94.6% for the Long Dilution Sequence for gentamicin when compared with the frozen Reference panel.

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

Quality Control testing demonstrated acceptable results for gentamicin.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

DEC - 8 2006

Re: k063365

Trade/Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels Gentamicin (0.06 - 32 µg/ml Long Dilution Sequence) 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: November 6, 2006 Received: November 15, 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 (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). 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, artom

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

KO63365 510(k) Number (if known):

Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Gentamicin (0.06 - 32 ug/ml Long Dilution 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℃ +/- 1℃, 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 gentamicin, at concentrations of 0.06 to 32 µg/ml Long Dilution Sequence for staphylococci, to the test panel.

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

Staphylococcus species (coagulase-positive and coagulase-negative) .

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)

Rudd, T. Poole

Vision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Suicty

Gm 510k_a.doc 11/6/2006

K063365

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