EL-ANA PROFILES: EL-ENA/5

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/10 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 AUG / 3 1998 Marius Teodorescu, M.D., Ph.D. President and CEO TheraTest Laboratories, Inc. 2201 W. Campbell Park Drive Chicago, Illinois 60612-3501 Re : K982622 EL-ANA Profiles: EL-ENA/5 Trade Name: Regulatory Class: II Product Code: LLL Dated: June 9, 1998 Received: June 18, 1998 Dear Dr. Teodorescu: 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, Druq, 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}------------------------------------------------ Page 1 of 1 510(k) Number (if known) K982622 Device Name: EL-ANA Profiles: EL-ENA/5 Indications for Use: The TheraTest EL-ANA Profiles: EL-ENA/5_is an in vitro diagnostic test for the screening of autoantibodies in human serum directed against the following extractable nuclear antigens: Sm, nRNP, SSA, SSB and Scl70. This screening aids in the diagnosis of systemic lupus erythematosus and related autoimmune disorders. Peter E. Maker ISTISION Sign-Off Unision of Clinical 510(k) Number (PLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGETE NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription use (Per 21CFR 801.109) OR Over-the-Counter use (Optional Format 1-2-96)