MICROSTREP PLUS PANEL, LEVOFLOXACIN

{0}------------------------------------------------ FEB 1 8 2000 ### 510(k) Summary ### 510(k) Submission Information: | Device Manufacturer: | Dade MicroScan Inc. | |----------------------|-----------------------------------------------------------------------------------------------------------------------------| | Contact name: | Cynthia Van Duker, Sr. Associate, Regulatory Affairs | | Fax: | 916-374-3144 | | Date prepared: | January 17, 2000 | | Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels | | Trade Name: | MicroScan® MICroSTREP plus™ Panel | | Intended Use: | To determine bacterial susceptibility to Levofloxacin | | Indication for Use: | For determining antimicrobic susceptibility of aerobic non-enterococcal<br>streptococci including Streptococcus pneumoniae. | | Predicate device: | MicroScan® Streptococcus MIC panel (K963641) | #### 510(k) Summary: MicroScan® MICroSTREP plus™ Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic nonenterococcal streptococci, including Streptococcus pneumoniae. 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 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. The proposed MicroScan® MICroSTREP plus™ Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991). The Premarket Notification (510[k]) presents data in support of the new MicroScan® MICroSTREP plus™ Panel with Levofloxacin. 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 MICroSTREP plus™ Panel by comparing its performance with an NCCLS frozen Reference panel. The MICroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 99% for Levofloxacin when compared with the frozen Reference panel. Reproducibility testing demonstrated acceptable reproducibility with Levofloxacin. Quality Control testing demonstrated acceptable results for Levofloxacin. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is black and white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 # FEB 1 8 2000 Ms. Cynthia Van Duker Sr. Associate Regulatory Affairs Dade Microscan, Inc. 1584 Enterprise Boulevard West Sacramento, California 95691 Re: K983943 > Trade Name: MicroScan® MICroSTREP plus™ Panel (Levofloxacin) Regulatory Class: II Product Code: JWY Dated: January 17, 2000 Received: January 18, 2000 Dear Ms. Van Duker: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {2}------------------------------------------------ Page 2 This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Butman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page **_ of _** | 510(k) Number (if known): | K983943 | |---------------------------|--------------------------------------| | Device Name: | MicroSTREP plus Panel - Levofloxacin | Indications For Use: The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative andor qualitative and/or qualitative The MicroScan® MICHS ITCLT plas - 1 ater is asoc to allet media of aerobic non-entercococcal antimicrobial agent susceptibility of colonies grown on solid media organizator f antiniticroolat agent susceptioning of collection, panels are incubation, panels are the siteplococci, including or epice oose proam. Incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Levofloxacin at concentrations of 0.002 - 16 mcg/ml to the test panel The organisms which may be used for Levofloxacin susceptibility testing in this panel are; I it organismis without may treptococci including Streptococcus pneumoniae. # PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) Woody Dubois 510(k) Number **Prescription Use** (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96)