KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT

{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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 MAY 2 2 2008 KRONUS Market Development Associates, Inc. c/o Ms. Heather Viele Director of Technical Affairs 12554 West Bridger Street Suite 108 Boise, ID 83713 Re: k080159 Trade/Device Name: KRONUS TSH Receptor Autoantibody (TRAb) ELISA Kit Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid autoantibody immunological test system Regulatory Class: Class II Product Code: JZO Dated: April 17, 2008 Received: April 18, 2008 Dear Ms. Viele: 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 application (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 such 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. 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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The {1}------------------------------------------------ Page 2 - 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Robert L. Becker Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Fobe assigned by FDA KO 8 2 15 9 Device Name: KRONUS TSH Receptor Antibody (TRAb) ELISA Assay Kit Indications for Use Statement: The KRONUS TRAb ELISA Assay Kit is for the semi-quantitative determination of antibodies to the thyroid stimulating hormone receptor in human serum. The KRONUS TRAb ELISA Assay is useful as an aid in the diagnosis of Graves' Disease in conjunction with other clinical and laboratory findings. (Please Do Not Write Below This Line - Continue On another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X (Pursuant to 21 CFR 801.109) OR Over-the-counter Use Mana M Chan Division Sign Off Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k080159