ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUM AN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a person with outstretched arms, composed of three curved lines. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 November 21, 2012 Acon Laboratories, Inc. c/o Qiyi Xie 10125 Mesa Rim Road San Diego, CA 92121 Re: k122110 Trade/Device Name: On Call® Vivid Pal Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, NBW Dated: November 7, 2012 Received: November 8, 2012 Dear Qiyi Xie: 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Page 2 - Qiyi Xie If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, ## Carol C: Benson for Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Form 510(k) Number (if known): Device Name: On Call Vivid Pal Blood Glucose Monitoring System Indications for Use: The On Call® Vivid Pal Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate (forearm and palm) testing sites should be used only when blood glucose level is not changing rapidly. The On Call® Vivid Blood Pal Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only. The On Call Vivid Blood Pal Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus, or use on neonates. The On Call Vivid Pal Blood Glucose Test Strips are used with the On Call Vivid Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm. The On Call Vivid Pal Blood Glucose Control Solution is for use with the On Call Vivid Pal Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR'801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Danise Dhmonteles vision Sign-Off Office of In Vitro Diagnostics and Radiological Health 510(k) K122110