SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID

K062705 · Dade Behring, Inc. · LON · Oct 20, 2006 · Microbiology

Device Facts

• Record ID: K062705
• Device Name: SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID
• Applicant: Dade Behring, Inc.
• Product Code: LON · Microbiology
• Decision Date: Oct 20, 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 linezolid, at concentrations of 0.5 to 16 ug/ml Long Dilution Sequence and 0.5 - 4 ug/ml 4-Dilution Breakpoint Sequence, for enterococci and staphylococci, to the test panel. The Gram-positive organisms which may be used for linezolid susceptibility testing in this panel are: Enterococcus faecium (vancomycin-resistant) Staphylococcus aureus (methicillin-susceptible and methicillin-resistant)

Device Story

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels determine antimicrobial susceptibility of Gram-positive cocci. Input: isolated colonies from solid media, prepared via turbidity method in saline/Pluronic® broth. Operation: panels are rehydrated/inoculated, then incubated in WalkAway®-SI system. System uses colorimetric optics (color wheel/lamp/photosensor) to detect growth via light detection. Output: quantitative MIC values and qualitative susceptibility interpretations. Used in clinical labs; operated by technicians. Rapid read (<16 hours) or overnight (16-24 hours) methods available. Output informs antibiotic therapy decisions; benefits include rapid susceptibility determination for targeted treatment.

Clinical Evidence

Bench testing only. Validation conducted using fresh and stock efficacy isolates and challenge strains. Performance compared against frozen reference panels. Results demonstrated acceptable essential agreement and categorical agreement for linezolid. Reproducibility testing confirmed acceptable performance using turbidity inoculum preparation and WalkAway® SI System. Quality control testing met acceptance criteria.

Technological Characteristics

Miniaturized broth dilution susceptibility test; dehydrated antimicrobial agents in microtiter plates. Rehydrated with Synergies plus™ Pos Broth. Incubation at 35°C ± 1°C. Automated reading via WalkAway® SI System or visual reading. Connectivity: Standalone or integrated with laboratory instrumentation.

Indications for Use

Indicated for testing Linezolid (0.5–16 µg/mL) on Gram-positive MIC/Combo panels for Enterococcus faecium (vancomycin-resistant) and Staphylococcus aureus (methicillin-susceptible and methicillin-resistant). For prescription use only. Resistance detection for Linezolid in Gram-positive isolates is unknown due to limited resistant strains; non-susceptible results require retesting and reference lab confirmation.

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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K062705

OCT 20 2006

## 510(k) Summary

510(k) Submission Information: Device Manufacturer: D Dade Behring Inc. Contact name: Robert Eusebio, Regulatory Affairs Manager 916-374-3144 Fax: Date prepared: August 21, 2006 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 antimicrobial - linezolid 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 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, 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 linezolid.

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

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Expected Results determined prior to the evaluation. The Synergies plus" Gram-Expected Results determined proprable performance with an overall Essential I ostire I and demonstrator association Sequence and 4-Dilution Agteencer of 76.070, 10, 10, 10, 10, 10, 10, 2019 - 10:15
Breakpoint Sequence, for Linezolid when compared with the frozen Reference panel.

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

Quality Control testing demonstrated acceptable results for linezolid.

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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

OCT 2 0 2006

Re: k062705 Trade/Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels Linezolid (0.5-16 µg/ml Long Dilution Sequence and 0.5 – 4 µg/ml 4 - Dilution Breakpoint 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: September 7, 2006 Received: September 20, 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 indicons for use stated in the enclosure) to legally marketed predicated devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical In microa in microsities 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, intiling 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 O intor gonetar in the 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

510(k) Number (if known):

Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Linezolid (0.5 - 16 ug/ml Long Dilution Sequence and 0.5 - 4 ug/ml 4-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℃ +/- 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 linezolid, at concentrations of 0.5 to 16 ug/ml Long Dilution Sequence and 0.5 - 4 ug/ml 4-Dilution Breakpoint Sequence, for enterococci and staphylococci, to the test panel.

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

> Enterococcus faecium (vancomycin-resistant) Staphylococcus aureus (methicillin-susceptible and methicillin-resistant)

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)

Luddi W. Poole
Division Sign-Off

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Lzd 510k.doc 10/11/2006

Office of In Vitro Diagnostic Device Evaluation and Safety

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