POLYTITER SYSTEM

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight. AUG 2 0 2001 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Helen Landicho, RAC Polymedco, Inc. 510 Furnace Dock Road, Cortlandt Manor, New York 10567 K012163 Re: Trade Name: PolyTiter Immunofluorescent Titration System Regulation Number: 21 CFR § 866.5100 Regulatory Class: II Product Code: DHN Dated: July 6, 2001 Received: July 11, 2001 Dear Ms. Landicho: We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your booms of substantially equivalent (for the indications for use above and we nave decommod the actected predicate devices marketed in interstate commerce stated in the encrosure) to regarly and date of the Medical Device Amendments, or to devices that provision in the roll be recordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the rec. "The general smanufacturing 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 (Frediation Applovary, it may be oubject Code of Federal Regulations, Title 21, Parts 800 to 895. alloomig your ac 1100 vient determination assumes compliance with the Current Good A subscliming 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 mspoonoms, the Food and 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 This letter will allow you to begin marketing your device as described in your 510(k) premarket I site lotter will and in your ding 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 11 you desire spooline arin vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (Joase 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 International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/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 V Enclosure {2}------------------------------------------------ 510(k) submission PolyTiter Immunofluorescent System ## SECTION 12.0 INDICATIONS FOR USE STATEMENT 510(k) NumberKO12163 Device Name: PolyTiter Immunofluorescent Titration System Indications For Use: The PolyTiter Immunofluorescent Titration System including the calibrator solutions is designed to assist in the semiquantitative determination (titer/pattern) of the and no Te-aDiscRips System may be in the in vitro microscopic immuno-fluorescent assay. The PolyTiter System may be used as an aid in the diagnosis and management of autoimmune diseases. en al C Donson (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K012163 (PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) V Prescription Use (Per 21 CFR 801.109) OR ## Over-The-Counter Use Polymedco, Inc.