AIA-PACK TPOAB ASSAY

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three human profiles within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. ## OCT 8 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Lori Robinson Manager, Quality Assurance TOSOH Medics, Inc. 373 D Vintage Park Drive Foster City, California 94404 Re: K981521/S1 > Trade Name: AIA-PACK TPOAb Assay Requlatory Class: II Product Code: JZO Dated: June 26, 1998 Received: July 14, 1998 Dear Ms. Robinson: 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 Requlations, 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 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 requlation 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 (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 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for TOSOH MEDICS, INC. The logo consists of a stylized four-leaf clover shape with a square in the center, along with the text "TOSOH MEDICS, INC." The word "TOSOH" is also written in a smaller font below the clover shape. The logo is simple and professional, and it is likely used to represent the company's brand. K98152 ## PREMARKET NOTIFICATION ## INDICATION FOR USE STATEMENT ## AIA-PACK TPOAb Assay AIA-PACK TPOAb is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroid peroxidase antibodies (TPOAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves' disease and Hashimoto's disease. Peter E. Macfmi. Division Sic 510(k) Number