ABBOTT ARCHITECT TOTAL T4

{0}------------------------------------------------ KC983440 ## 510(k) Summary Abbott ARCHITECT™ Total Ta ## Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination The following information as presented in the Premarket Notification [510(k)] for Abbott ARCHITECT™ Total T, constitutes data supporting a substantially equivalent determination. ARCHITECT Total T, is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total T , in human serum or plasma (lithium heparin, sodium heparin. or potassium EDTA). ARCHITECT Total T, is calibrated with ARCHITECT Total T, Calibrators. ARCHITECT Total T, Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System. Substantial equivalence has been demonstrated between the ARCHITECT Total T. assay and the AxSYM® Total T. assay. The intended use of both assays is for the quantitative determination of total T. in human serum and plasma. Least squares linear regression analysis of an ARCHITECT Total T. vs. AxSYM Total T. comparison, using 1155 specimens, gave the following parameter estimates: correlation coefficient = 0.928. slope = 1.01 and y-axis intercept = - 0.11 ug/dL. Passing-Bablok linear regression analysis of an ARCHITECT Total T, vs. AxSYM Total T, comparison, using 1155 specimens, gave the following parameter estimates: correlation coefficient = 0.928, slope = 0.99 and yaxis intercept = - 0.13 ug/dL. In conclusion, these data demonstrate that the ARCHITECT Total T2 assay is as safe and effective as, and is substantially equivalent to, the AxSYM Total Ta assay. Prepared and Submitted September 28, 1998 by: April Veoukas, J.D. Senior Regulatory Specialist ADD Regulatory Affairs (847) 937-8197 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537 ARCHITECT™ Total T2 510(k) September 1998 {1}------------------------------------------------ Public Health Service ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/2 description: The image shows a partial view of a document with a seal and some text. The seal on the left includes the words "DEPARTMENT OF HEALTH & HUMA". To the right of the seal, the text "NOV 25" is visible, suggesting a date or reference number. The document appears to be official, possibly from a government or health-related organization. NOV 2 5 1998 Ms. April Veoukas, J.D. Senior Regulatory Specialist ADD Requaltory Affairs Abbott Laboratories 200 Abbott Park Road Abbott Park, Illinois 60064-3537 Re: K983440 Trade Name: Abbott ARCHITECT™ Total T. Regulatory Class: II Product Code: KLI JIT II JJX I Dated: September 28, 1998 September 29, 1998 Received: Dear Ms. Veoukas: 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 requlation (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. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 {2}------------------------------------------------ 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 regulation entitled, "Misbrandinq by reference to premarket notification"(21 CFR 807.97). Other qeneral 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 Sutman 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 {3}------------------------------------------------ 510(k) Number (if known): \$98340 Abbott ARCHITECT™ Total T4 Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The ARCHITECT™ Total T (TT ) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of thyroxine (total T.) in human serum and plasma. The ARCHITECT Total T assay is to be used as an aid in the assessment of thyroid status. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Image /page/3/Figure/5 description: The image shows the concurrence of CDRH, Office of Device Evaluation (ODE). There are two options: Prescription Use (Per 21 CFR 801.109) or Over-The-Counter Use (Optional Format 1-2-96). An arrow points to the Prescription Use option. sion Sign-Off) ical Laboratory Devices 510(k) Manager K983446