HARDYDISK AZTREONAM, 30MCG

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, stacked on top of each other. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 ## JAN 1 4 2000 Ms. Melissa M. Traylor, RAC Director of Technical Services Regulatory Affairs Hardy Diagnostics 1430 West McCoy Lane Santa Maria, California 93455 Re: K994063 > Trade Name: HardyDiskTM Aztreonam 30mcg Regulatory Class: II Product Code: JTN Dated: November 29, 1999 Received: December 1, 1999 Dear Ms. Traylor: 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. {1}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655. 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" (21 CFR 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" Sincerely vours. Steven Autman 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 {2}------------------------------------------------ . Image /page/2/Picture/3 description: The image shows the logo for Hardy Diagnostics. The logo consists of a circular graphic on the left and the text "HARDY DIAGNOSTICS" on the right. The circular graphic is black and white and appears to have several lines running through it. The text is in a bold, sans-serif font, with "HARDY" on top and "DIAGNOSTICS" below. Forail: Sales Bitaria Lannstics com und Merid. na Maria, CA 9345 Tel. 1.3051 346-27 > Is Laste City, Uce 54 Kr. Concercial C SADOY. UI 144010 Tct: 18001 995-4273 19011567 7714 1999 Ave 510K Number K994063 ## Indications for Usc Statement-HardyDisk™ Aztreonam 30mcg I lardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test proccdure (Kirby-Baucr) of rapidly growing and corain fastidious bactcrial pathogens. Standardized mothods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococous spp., Pscudomonas spp., Acinesobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Ilacmophilus influenzas. Neisseria gonorrhocas and Streptococcus pneumoniae. HardyDisk™ Aztroottam is indicated for in vitro activity against gram negative aerobic pathogens including Escherichia coli, Enterobacter spp., Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens, and C.itrobacter spp. HardyDisk™ Aztreonam is also indicated for in vitro activity against Haemaphilus influenzae. <Hind> Concurrence of CDRH-ODE Woody Dubois Laboratory Devices Division of Clini 510(k) Number Prescription Use (per 21 CFR 801.109) OR Over-the Counter-lise. (( Intional format 1-2-96) Scring the laboratorian since: 1990