MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML)

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 AUG 3 0 2004 Mr. Robert Eusebio Manager Regulatory Affairs Dade MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691 Re: k023361 Trade/Device Name: MicroScan® Synergies Plus Gram Negative MIC/Combo Panels With Gatifloxacin (0.004 - 16 ug/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON Dated: July 30, 2004 Received: August 3, 2004 Dear Mr. Eusebio: This letter corrects our substantially equivalent letter of December 16, 2002, regarding the trade name which was changed to MicroScan® Synergies Plus to better reflect the intended use of the device. 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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to continue 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-3084. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Fuddie Lu. Pate fo 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 {2}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): K023361 Device Name: MicroScan® Synergies plus " Gram-Negative MIC/Combo Panels with Gatifloxacin (0.004 – 16 µg/ml) #### Indications For Use: MicroScan® Synergies plus™ Gram-Negative 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-Negative bacilli (Enterobacteriaceae, glucose nonfermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® S7 System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert. This particular submission is for the antimicrobial Gatifloxacin on the Synergies plus" Gram-Negative MIC/Combo Panels. The Gram-Negative organisms which may be used for Gatifloxacin susceptibility testing in this panel are: > Escherichia coli Klebsiella pneumoniae Proteus mirabilis Acinetobacter lwoffii Citrobacter koseri Proteus vulgaris Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii Prescription Use (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) Fredda W. Cole Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of _ 1 510(k) K023361 {3}------------------------------------------------ ### 510(k) Summary ## DEC 1 6 2002 ### 510(k) Submission Information: | Device Manufacturer: | Dade Behring Inc. | |----------------------|-------------------------------------------------------------| | Contact name: | Cynthia Van Duker, Manager Regulatory Affairs | | Fax: | 916-374-3144 | | Date prepared: | October 3, 2002 | | Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels | | Trade Name: | MicroScan rapID/S plus™ Gram-Negative MIC/Combo panels | | Intended Use: | To determine antimicrobial agent susceptibility | | 510(k) Notification: | Antimicrobials: Gatifloxacin | | Predicate device: | MicroScan Dried Gram Negative MIC/Combo Panels | #### 510(k) Summary: MicroScan rapID/S plus ™ Gram-Negative MIC/Combo Panels 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-negative bacilli. The MicroScan rapID/S plus ™ Gram-Negative MIC/Combo Panels are read on the WalkAway SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments). The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth to concentrations bridging the range of clinical interest and are presented in micro-titer wells in dried form. rapID/S plus ™ panels are inoculated and rehydrated with a standardized suspension of the organism and incubated at 35℃ in the WalkAway® SI System or equivalent for 4.5 - 18 hours. The minimum inhibitory concentration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth. The proposed MicroScan rapID/S plus™ Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000. The Premarket Notification (510[k]) presents data in support of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel with Gatifloxacin. 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 rapID/S plus ™ Gram-Negative Panel by comparing its performance with an NCCLS frozen Reference panel. Challenge strains were compared to Frozen Results determined prior to the evaluation. The rapID/S plus ™ Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 98.8% (399/404) and Categorical Agreement of 96.5% (306/317) compared with the frozen Reference panel. Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Gatifloxacin with Turbidity inoculum preparation method and the WalkAway® SY System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments). Quality Control testing demonstrated acceptable results for Gatifloxacin.