ABBOTT AXSYM TROPONIN-I ADV

{0}------------------------------------------------ # 510(k) Summary 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. The AxSYM Troponin-I ADV assay is a Microparticle Enzyme Immunassay for the quantitative determination of cardiac troponin-I in human serum or plasma. The AxSYM Troponin-I ADV assay is calibrated with AxSYM Troponin-I ADV Standard Calibrators. AxSYM Troponin-I ADV Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System. 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 or plasma. The intended use of the Beckman Coulter Access Accu TnI assay is for the quantitative determination of cardiac troponin I in human serum and plasma. A correlation analysis between the two assavs vielded the following results. | 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 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. {1}------------------------------------------------ Prepared and Submitted 31 August 2004 by: Margaret Prochniak, M.S. Senior Regulatory Specialist ADD Regulatory Affairs Phone: (847) 937-4106 Fax: (847) 937-9616 E-mail: Margaret.Prochniak@abbott.com Abbott Laboratories Diagnostics Division Department 9V6, Building AP6C-3 100 Abbott Park Road Abbott Park, IL 60064-6095 {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 consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 SEP 1 0 2004 Ms. Margaret Prochniak, M.S Sr. Regulatory Affairs Specialist Abbott Laboratories Diagnostics Division Dept. 9V6, Bldg. AP6C-3 100 Abbott Park Road Abbott Park, IL 60064-6095 k041811 Re: Trade/Device Name: Abbott AxSYM® Troponin-I ADV Abbott AxSYM® Troponin-I ADV Standard Calibrators Abbott AxSYM® Troponin-I ADV Controls Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI, JIT, JJX, Dated: July 2, 2004 Received: July 6, 2004 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 {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 (301) 594-3084. 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/dsma/dsmamain.html. Sincerely yours, Jean M. Cooper US. DVM. Tean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### ATTACHMENT 1 ### Indications for Use 510(k) Number (if known): K041811 Device Name: Abbott AxSYM® Troponin-I ADV Abbott AxSYM® Troponin-I ADV Standard Calibrators Abbott AxSYM® Troponin-I ADV Controls Indications For Use: The AxSYM Troponin-I ADV assay 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) The AxSYM Troponin-I ADV Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of cardiac troponin-I in human serum or plasma. The AxSYM Troponin-I ADV Controls are for the estimation of test precision and the detection of systematic analytical deviations of the AxSYM System (reagents, calibrators, and instrument) when used for the quantitative measurement of cardiac troponin-l in human serum or plasma. 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 C. Benson Division Sign-Off Page 1 of 1 Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K041811