ACTIVE INTACT PTH

{0}------------------------------------------------ K973514 145 Medical Center Boulevard Vabster Texas 77598-4217 USA Tel 281 332 9678 281 554.4220 OCT 3 1 1997 Tel 800.231.7970 Fax 281.338.1895 Email mktg@dslabs.com ## SUMMARY OF SAFETY AND EFFECTIVENESS Name of Device: Classification Name: Analvte Name: Requlatory Class: DSL 9300 ACTIVE™ I-PTH Coated Bead IRMA Kit Immunoradiometric Assay, I-PTH Intact Parathyroid Hormone 11 Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: 281-332-9678 September 16, 1997 Date: The DSL ACTIVE™ I-PTH Coated Bead IRMA kit was developed for the quantitative measurement of the intact molecule PTH in human serum. This Coated Bead IRMA format is a capture assay. Goat polyclonal antibody to PTH is immobilized to the surface of the coated bead. I-PTH in the standards or serum samples is "sandwiched" between this polyclonal antibody and the anti-I-PTH goat polyclonal antibody radiolabeled for detection with I-125. The DSL ACTIVE™ I-PTH Coated Bead IRMA assay is intended for the quantitative determination of I-PTH in human serum. This assay is intended for in vitro diagnostic use. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism. The DSL ACTIVE™ I-PTH Coated Bead IRMA is substantially equivalent to the DSL 8000 ACTIVE™ I-PTH IRMA. Both kits have the same intended use. To demonstrate substantial equivalence between the two assays, patient samples (n = 97) were collected and assayed simultaneously by both methods. Samples were chosen based on expected I-PTH levels so that samples with low, intermediate and high levels of I-PTH would be evaluated. Linear regression analysis of the results obtained for the comparison with the I-PTH assay gave the equation Y = 0.93(X) + 33.81 with a correlation coefficient of (r) = 0.97. {1}------------------------------------------------ Image /page/1/Picture/2 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 three human profiles facing right, stacked on top of each other. The profiles are abstract and created with thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the image. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 3 1 1997 John Willis . Director of Requlatory Affairs Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster Texas 77598 Re: K973514 DSL 9300 ACTIVE I-PTH Coated Bead IRMA Kit Requlatory Class: II Product Code: CEW Dated: September 16, 1997 Received: September 17, 1997 Dear Mr. Willis: requlations. 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 {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 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 Gutman 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: ACTIVE™ Intact PTH IRMA Indications For Use: The DSL ACTIVE™ I-PTH Coated Bead IRMA assay is intended for the quantitative determination ine DOE NOTAL - 11 11 Octob Bout inintended for in vitro diagnostic use. Measurements of ണി 11 ന് നിന്നീണ് ശേഷം 16 the differential diagnosis of hypercalcemia (abnormally partnyrola fecalcium in the blood) and hypocalcemia (abnormally low levels of calcium in the lighters blood) resulting from disorders of calcium metabolism. ## PEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) *escription Use Per 21 CFR 801.109) OR Over-The-Counter Use ( (Division Sign-Off) Division of Clinical I 510(k) Number _