IL TEST PROTEIN C

{0}------------------------------------------------ K980875 ## APR 21 1998 Section 3 IL Test™ Protein C - 510(k) SUMMARY (Summary of Safety and Effectiveness) #### Submitted by: Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (781) 861-4467 (781) 861-4464 Fax: ### Contact Person: Carol Marble Phone: (781) 861-4467 ## Summary Prepared: March 5, 1998 #### Name of the device: IL Test™ Protein C ### Classification name(s): 864.7290 Factor Deficiency Test Class II Test, Qualitative and Quantitative Factor Deficient 81GGP ## Identification of predicate device(s): K922201 Coamatic® Protein C ## Description of the device/intended use(s): IL Test™ Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate. Protein C deficiency is associated with recurrent venous thrombosis, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation. ## Statement of How the Technological Characteristics of the Device Compare to the Predicate device: The new IL Test™ Protein C uses the same test principle as the predicate Coamatic® Protein C and is substantially equivalent in performance, intended use and safety and effectiveness. #### Summary of Performance Data: In method comparison studies evaluating 52 plasma samples, the correlation (r) was 0.990 for the new IL Test™ Protein C on the ACL 300 as compared to the predicate Coamatic® Protein C on the Cobas Mira and 0.996 for the new IL Test™ Protein C on the ACL Futura as compared to the predicate Coamatic® Protein C on the Cobas Mira. On the ACL 300, within run precision assessed over multiple runs using 2 levels of plasma gave a CV of 1.6% (at a mean of 52.4% activity) and 1.4% (at a mean of 104.6% activity). On the ACL Futura, within run precision accessed over multiple runs using 2 levels of plasma gave a CV of 2.1% (at a mean of 51.4% activity) and 1.4% (at a mean of 105.6% activity). IL Test™ Protein C 510(k) : {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and the pursuit of well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Carol Marble .Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190 Re : K980875 IL TEST™ Protein C Regulatory Class: II Product Code: GGP Dated: March 5, 1998 March 6, 1998 Received: 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, 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 regulatory In addition, FDA may publish further announcements action. 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 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}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: IL Test™ Protein C # Indications for Use: IL Test™ Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate. Protein C deficiency is associated with recurrent venous thrombosis, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) P. Berlaust (for A. Montgomery) Sir Off (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K980875 Prescription Use (Per 21 CFR 801.019) OR Over-The-Counter Use Section 2 IL Test™ Protein C 510(k) Page 1 of 1