DSL ACTIVE T4 EIA

{0} K971269 MAY 22 1997 SUMMARY OF SAFETY AND EFFECTIVENESS Name of Device: DSL 10-3200 ACTIVE™ T4 EIA Kit Classification Name: Enzymeimmunoassay, T4 Analyte Code and Name: T4 Regulatory Class: II Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: 281-332-9678 Date: May 14, 1997 The DSL ACTIVE™ T4 EIA kit was developed for the quantitative measurement of T4 in human serum. The EIA format is a competitive binding protein assay. Enzyme-labeled T4 competes with un-labeled T4 in the serum sample for binding sites with the Anti-T4 antibody in microtitration wells. Separation of free from bound T4 is achieved by washing and decanting the microtiter plates after incubation. The resultant is analyzed in a spectrophotometer for absorbance. The amount of enzyme-labeled T4 bound to the antibody is inversely proportional to the concentration of the T4 present in the sample. The DSL ACTIVE™ T4 EIA assay is intended for the quantitative determination of T4 in human serum. The measurement of T4 is used in the diagnosis and treatment of thyroid disease. The DSL ACTIVE™ T4 EIA is substantially equivalent to the DSL ACTIVE™ T4 RIA. To demonstrate substantial equivalence between the two assays, patient samples (n = 59) were collected and assayed using both methods. Samples were chosen based on expected T4 levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation $Y = 0.72(X) - 0.24$ with a correlation coefficient of $(r) = 0.96$. {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 MAY 22 1997 John Willis Director of Regulatory Affairs Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Re: K971269 DSL 10-3200 ACTIVE™ T4 EIA Kit Regulatory Class: II Product Code: KLI Dated: April 3, 1997 Received: April 4, 1997 Dear Mr. Willis: 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. {2} Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. 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, "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/dsmamain.html". Sincerely yours, 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): Device Name: Thyroxine (T4) EIA Indications For Use: The DSL-10-3200 T4 Enzymeimmunoassay (EIA) Kit provides materials for the quantitative measurement of T4 in serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of thyroid disease. (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)  Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use