ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138

{0}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. The bottom half of the circle contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES". In the center of the seal is an image of an eagle. Siemens Healthcare Diagnostics, Inc. c/o Dr. Kira Gordon Regulatory Affairs and Compliance 511 Benedict Avenue Tarrytown, New York 10591 Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993 AUG 4 2010 k100200 Re: > Trade name: ADVIA® Chemistry Acetaminophen Reagent Regulation Number: 21 CFR 862.3030 Regulation Name: Acetaminophen test system. Regulatory Class: Class II Product Code: LDP Dated: July 16, 2010 Received: July 19, 2010 #### Dear Dr. Gordon: 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {1}------------------------------------------------ Page 2 If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, CA Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known): k100200 Device Name: ## AUG 0 4 2010 ADVIA® Chemistry Acetaminophen Reagent Indications For Use: For in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems. Such measurements are used in the detection of acetaminophen overdose. ﯿﮯ Prescription Use _ (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C) ﺮ ﺃﻣﺮ ### (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) And/Or Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Signature Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K / OQ 200