EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "HUMAN SERVICES - USA - DEPARTMENT" is written around the circumference of the circle. ## DEPARTMENT OF HEALTH & HUMAN SERVICES EPS Bio Technology Corp. c/o Y. C. Lei General Manager 2F, No. 49-2, Lane 2 Guang Fu Rd., Sec. 2 Hsinchu City, (Taiwan) China 30071 Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002 # OCT 2 1 2009 k092887 Re: > Trade Name: EasyPlus Mini MasterDriver SMBG System Regulation Number: 21 CFR \$862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW, CGA Dated: September 18, 2009 Received: September 21, 2009 Dear Y.C. Lei: 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 Form K092887 510(k) Number (if known): #### EasyPlus mini MasterDriver SMBG system Device Name: #### Indications for Use: #### EasyPlus mini MasterDriver SMBG Test System The EasyPlus mini MasterDriver SMBG Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. #### EasyPlus mini MasterDriver Meter The EasyPlus mini MasterDriver Meter is intended for the quantitative measurement of glucose in fresh capillary The Easy 160 min habert in on the fingertips or forearm. EasyPlus mini MasterDriver Blood Glucose Test Strips must be used with the EasyPlus mini MasterDriver Meter. Testing is done outside the body (In Vitro diagnostic use). rnust of dood with the Each nover the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. #### EasyPlus mini MasterDriver Blood Glucose Test Strips The EasyPlus mini MasterDriver Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingerips or forearm. EasyPlus mini MasterDriver Blood in fresh oppliary while blood sen with the EasyPlus mini MasterDriver Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. ### EasyPlus mini MasterDriver Glucose Control Solutions For use with the EasyPlus mini MasterDriver meter and EasyPlus mini MasterDriver Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. | Prescription Use (Part 21 CFR 801 Subpart D) | AND/OR | |-----------------------------------------------|--------| |-----------------------------------------------|--------| OR Over-The-Counter Use_ V (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 Diagnostic Devices (OIVD) y Division Siart-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K092887