COAMATIC PLASMINOGEN

{0}------------------------------------------------ K9 74711 Section 3 MAY | 1998 # Coamatic® Plasminogen - 510(k) SUMMARY (Summary of Safety and Effectiveness) ## Submitted by: - Carol Marble Regulatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington. MA 02173 Phone: (781) 861-4467 Fax: (781)861-4464 ## Contact Persons: Carol Marble Phone: (781) 861-4467 ## Summary Prepared: December 16, 1997 ## Name of the device: Coamatic® Plasminogen ## Classification name(s): Factor Deficiency Test Class II 864.7290 Test. Qualitative and Quantitative Factor Deficient 81GGP # Identification of predicate device(s): Coatest® Plasminogen K854572 # Description of the device/intended use(s): Coamatic® Plasminogen is an in vitro diagnostic test for the quantitative determination of plasminogen (Plg) activity in human citrated plasma on automated laboratory equipment and also using microplate and manual methods. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders. # Statement of How the Technological Characteristics of the Device Compare to the Predicate device: Coamatic® Plasminogen uses the same general test principle as the predicate Coatest® Plasminogen with the exception that Fibrinogen is added to the Streptokinase reagent to avoid the risk of overestimation of plasminogen in pathological plasmas containing elevated levels of fibrinogen (fib) and/or fibrin degradation products (FDP). The tests are substantially equivalent in performance, intended use, and safety and effectiveness. #### Summary of Performance Data: In method comparison studies comparing the new Coamatic® Plasminogen to the predicate Coatest® Plasminogen, the correlation (r) on an ACL 300 (n=59) was 0.92, on a Cobas Mira S (n=41) was 0.97, on a Cobas Bio (n=30) was 0.97, on a Cobas Fara (n=30) was 0.97, on a EPOS 5060 (n=32) was 0.99, on an MLA (n=37) was 0.98 and using the test tube (n=23) and microplate (n=31) methods was 0.92 and 0.93, respectively. Within run precision accessed over multiple runs gave a CV of 1.9% (at a mean plasminogen concentration of 49%) and 1.5% (at a mean plasminogen concentration of 96%). Section 3 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, depicted with flowing lines to suggest movement or flight. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 1 1998 MAY Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190 ・・ Re : K974711 Coamatic® Plasminogen Regulatory Class: II Product Code: GGP Dated: April 8, 1998 Received: April 9, 1998 Dear Ms. Marble: 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 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. ಗಳ 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 regulation may result in requlatory 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 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/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}------------------------------------------------ Indications for Use Statement 510(k) Number (if known): k974711 Device Name: Coamatic® Plasminogen # Indications for Use: Coamatic® Plasminogen is an in vitro diagnostic test for the quantitative determination of plasminogen (Plg) activity in human citrated plasma on automated laboratory equipment and also using microplate and manual methods. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders. # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | | Concurrence of CDRH, Office of Device Evaluation (ODE) | |---------------------------------------|--------------------------------------------------------| | (Division Sign-Off) | | | Division of Clinical Laborato | | | 510(k) Number | | | Prescription Use (Per 21 CFR 801.019) | OR Over-The-Counter Use | | Section 2 | Coamatic® Plasminogen 510(k) | | | Page 1 of 1 |