SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the numbers 26 and 16. The number 26 is on the left side of the image, and the number 16 is on the right side of the image. The numbers are written in a simple font and are easy to read. The background of the image is white. Image /page/0/Picture/1 description: The image shows the logo of Sanqui BioTech, Inc. The logo consists of a circular emblem on the left and the company name on the right. The emblem features a stylized globe with the words "SANGUI" and "BIOTECH" encircling it. The company name, "Sanqui BioTech, Inc.," is written in a bold, sans-serif font. 1508 Brookhollow Drive, Suite 354 Santa Ana, California 92705 USA 714-429-7807 (Voice) 714-429-7808 (Fax) DEC 2 3 1997 ## 510 (k) SUMMARY SECTION 9: Name of Contact Person: John J. Kiang or Patrick Onishi. Name of Proposed Device: Sangui BioTech, Inc. INTACT-PTH [Parathyroid Hormone1 ELISA Common name of the device: Intact PTH (Parathyroid hormone) in vitro Diagnostic Kit Classification name: Radioimmunoassay, Parathyroid hormone Name of Predicate Device: Nichols Institute Diagnostics Allégro® Intact PTH (Parathyroid Hormone) kit, to which this firm claims substantial equivalency. Description of the proposed device: Quantitative determination of Intact Parathyroid Hormone (PTH) in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA). Intended Use of the proposed device: The intended use of this product is the quantitative determination of Intact Parathyroid Hormone (PTH) in human serum. Technological characteristics: Similarities: - the intended use o - The antibodies used, which are all polycolonal antibodies from goats and are all o purified via affinity chromatography. - Both kits are based on immunometric (sandwich) assay principles. ර - Analytical sensitivity. o Technological characteristics: Differences: - Sample size o - Incubation or reaction time for the immunoassay. - Tag [ enzyme label antibody vs. radiolabeled antibody]. - Solid Phase. Based on the study on one hundred and twenty-three (123) patient sera analyzed using both the proposed device and the predicate device, a correlation coefficient (R) of 0.99 was obtained with a slope of 0.997 and an intercept of 2.9. The samples studied ranged from 3.2 to 805 pg/mL of intact PTH in the Nichols' kit. The data clearly demonstrates excellent correlation between the two devices. Further, another predicate device, the ACTIVE ™ I-PTH ELISA kit, currently manufactured by Diagnostic Systems Laboratories, Inc. (DSL), Webster, Texas 77598-4217, uses the same principle, ELISA, as this proposed device. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the wings and body. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 ## DEC 2 3 1997 John J. Kianq, M.S. · President and CEO Sanqui BioTech, Inc. 1508 Brookhollow Drive 92705 Santa Ana, California K974306 Re : INTACT-PTH [Parathyroid Hormone] ELISA Diagnostic Kit Requlatory Class: II Product Code: CEW November 13, 1997 Dated: November 31, 1997 Received: Dear Mr. Kiang: 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 Sitman 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}------------------------------------------------ Section 6c: Statement of Indications for Use **510 (k) Number:** K974306 Device Name: Sangui BioTech, Inc. INTACT-PTH (Parathyroid Hormone) ELISA ## Indications For Use: The intended use of this product is the quantitative determination of Intact Parathyroid Hormone (PTH) in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA). The measurement of parathyroid hormone levels in the disease states is intended for the differential diagnosis of hypercalcemia and hypocalcemia resulting from the disorders of calcium metabolism. UMclardy Montgomery ivision of Clinical I (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 Format 1-2-96)