ABBOTT AXSYM TROPONIN-I ADV

{0}------------------------------------------------ K060875 ### 510(k) Summary JUN 1 4 2006 ## Abbott AxSYM® Troponin-I ADV # Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination The following information as presented in the Premarket Notification [510(k)] for Abbott AxSYM Troponin-I ADV constitutes data supporting a substantially equivalent determination. Substantial equivalence has been demonstrated between the AxSYM Troponin-I ADV assay and the Beckman™ Coulter Access® AccuTnI assay The intended use of the AxSYM Troponin-I ADV assay is for the quantitative determination of cardiac troponin-I in human serum and plasma to assist in the diagnosis of myocardial infarction, and in the risk stratification of patients with acute coronary syndromes, (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events. The intended use of the Beckman Coulter Access AccuTnI assay is for the quantitative determination of cardiac troponin-I in human serum and plasma to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac troponin-I determination aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures. | Regression Method | n | r | Slope | Intercept | |---------------------------------------|-----|------|-------|-----------| | Passing-Bablok<br>(All Specimens) | 546 | 0.97 | 1.47 | -0.05 | | Passing-Bablok<br>(ADV Dynamic Range) | 531 | 0.95 | 1.47 | -0.05 | n = number of specimens r = correlation coefficient {1}------------------------------------------------ In conclusion, these data demonstrate that the AxSYM Troponin-I ADV assay is as safe and effective as, and is substantially equivalent to, the Beckman Coulter Access AccuTnI assay. Prepared and submitted 29 March 2006 by: Margaret Derchinik 3/29/06 Abbott Laboratories Margaret Prochniak, M.S. Sr. Regulatory Affairs Specialist ADD Regulatory Affairs Dept. 9VA, Bldg AP6C-2 100 Abbott Park Road Abbott Park, IL 60064-3500 Phone: (847) 937-4106 Fax: E-Mail: Margaret.Prochniak@abbott.com {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. #### Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Margaret Prochniak, M.S. Sr. Regulatory Affairs Specialist ADD Regulatory Affairs Abbott Laboratories Diagnostics Division Dept. 9VA AP6C-2 100 Abbott Park Road Abbott Park, IL 60064-3500 JUN 1 4 2006 Re: k060875 > Trade/Device Name: Abbott AxSYM® Troponin-I ADV Reagent Regulation Number: 21 CFR§862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: March 29, 2006 Received: March 30, 2006 Dear Ms. Prochniak: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {3}------------------------------------------------ #### Page 2 - This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Alberto Guti Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known):_KOLeO875 Device Name: Abbott AxSYM® Troponin-I ADV Reagent Indications For Use: The AxSYM Troponin-1 ADV reagent is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Carol Benson Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K060875