TOTAL THROXINE MICROPLATE EIA(225-300)

{0}------------------------------------------------ K971709 JUN 1 6 1997 Image /page/0/Picture/2 description: The image is a logo for MONOBIND, INC. The logo features a stylized, interconnected design resembling the letters 'm' and 'b' stacked on top of each other. The letters are bold and black, creating a strong visual impact. Below the symbol, the company name "MONOBIND, INC." is printed in a simple, sans-serif font. May. 7, 97 510(k) Summarv Dear Sir: Monobind Inc. , registration number 2020726, plans to introduce into commercial distribution an enzymelmmunoassay (EIA) kit for the determination of total thyroxine (T4) In human serum or plasma. The proprietary name is Total Thyroxine (T4) Microplate EIA and the usual name is T4 EIA. This device classification name is - enzyme immunoassay, non-radiolabeled, total thyroxine - product code 75KLI (per 21 CRF section 862.1700). This device is substantially equivalent to the Monobind total thyroxine (T4) coated tube radioimmunoassay (RIA), which predicates the new device. The contact individual for this submission is Dr. Frederick R. Jerome. The Monobind microplate EIA utilizes anti-thyroxine antibody immobilized on the surface of plastic wells of a microtiterplate. Specimens, calibrators or controls are then added followed by the enzyme-T4 conjugate. A competition reaction results between the native thyroxine in the sample and the added enzyme-T4 conjugate for a limited number of antibody combining sites. After the completion of the incubation period, the enzyme-T4 conlugate is separated from unreacted material by decantation. The activity of the enzyme on the well is quantitated by reaction with suitable substrate to produce color. The Intended use of the device: The quantitative determination of total thyroxine concentration in human serum or plasma by a microplate enzymelmmunoassay. The technological characteristics of the new device compared to the predicate device are essentially Identical. This Includes the use of the same anti-thyroxine antibody (coated on a plastic surface), identically prepared callbrators, sample size and the composition of the tracer buffer. The sole difference resides in the use of an enzyme tracer compared to a radioisotope. Substantial equivalency was based on clinical comparison (linear regression), using 131 specimens from hypothyroid, euthyroid and hyperthyroid populations. The mean values for reference method (coated tube RIA) and this method (microplate EIA) are 8.07 and 8.06 respectively. The equation to a straight line (y= 0.39 + 0.952) and correlation coefficient (0.934) indicates good method agreement. In addition recovery data demonstrated an average recovery of 101.1% when exogenous added thyroxine was introduced into human serum specimens. Similarly, linearly studies showed an average 101.2% when a specimen was diluted and compared to the dose response curve. 729 West 16" Street , Costa Mesa , CA (USA) 92627 Phone: (714) 642-4830 FAX: (714) 650-8459 {1}------------------------------------------------ Public Health Service JUN 16 1997 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Dr. Frederick R. Jerome Monobind, Inc. 729 West 16th Street --Costa Mesa, California 92627 K971709 Re: Total Throxine Microplate EIA (225-300) 学 Regulatory Class: II Product Code: KLI Dated: May 7, 1997 Received: May 8, 1997 Dear Dr. Jerome: 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 The general controls provisions of the Act 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 Reqister. 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 requlations. {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 acborizoof 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. :李 If you desire specific advice for your device on our labeling requlation (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 Autman 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}------------------------------------------------ ## Indications for Use Statement 510(k) Number (if known): K971709 Device Name: Total Thyroxine (T4) Microplate EIA 体 The quantitative determination of total thyroxine concentration in human serum or plasma by a microplate enzymeimmunoassay.Measurements obtained from this device are used in the diagnosis and treatment of thyroid diseases. (Division Sign-Off Division of Clinical Laboratory vices 510(k) Number. 974709 (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 (Optional Folmat 1-2-96)