MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM

{0}------------------------------------------------ K070239 MAY 2 5 2007 # 510 (k) Summary Page 1-of-2 1. Submitter Information Company name Contact person Address Phone FAX E-mail Date Prepared 2. Name of Device Trade Names Common Names/Descriptions Classification Names Exir Pharmaceutical Company Pejman Hosseinpour No.15,Rahmati alley,Valiasr st., (North of Valiasr sq.), Tehran, Iran, 15949 0098 ( ) 2188918466-7 0098 ) 2188899358 ( Hoseinpour@exir.co.ir Hoseinpour@exirpharma.com Jan 18th , 2007 Maximed Exichek TD 4224 Blood glucose monitoring system Blood Glucose Meter Blood Glucose Test Strips Class II devices (21 CFR Section 862.1345, Glucose Test System) 3. Predicate Device Trade/Proprietary Name: Common/Usual Name: Manufacturer 510 (k) Number Clever Chek TD-4223 blood glucose monitoring system Blood Glucose Meter Blood Glucose Test Strips TaiDoc Technology Corporation K063212 {1}------------------------------------------------ ### 4. Device Description Maximed Exichek TD 4224 blood glucose monitoring system consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions. #### 5. Intended Use Maximed Exichek TD 4224 blood glucose monitoring system is indicated for the quantitative measurement of glucose in fresh capillary whole blood taken from the finger and the alternative sites for self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities. Testing is done outside the body (in vitro diagnostic use). The alternative site testing (the plam, the forearm, the upper arm, the calf and the thigh) in this system can be used only during steady-state blood glucose conditions. ## 6. Comparison to Predicate Device Maximed Exichek TD 4224 blood glucose monitoring system has equivalent technological characteristics as the Clever Chek TD-4223 blood glucose monitoring system (K063212). Maximed Exichek TD 4224 blood glucose monitoring system also has the same intended use as the lever Chek TD-4223 blood glucose monitoring system ## 7. Performance Studies The performance of Maximed Exichek TD 4224 blood glucose monitoring system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use. ### 8. Conclusion Maximed Exichek TD 4224 blood glucose monitoring system demonstrates satisfactory performance and is suitable for its intended use. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in a circular arrangement. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Exir Pharmaceutical Company c/o Erica Li TaiDoc Technology Corporation 4F, No. 88, Sec. 1, Kwang-Fu Rd., San-Chung - Taipei County Taiwan 241 MAY 2 5 2007 k070239 Re: Trade/Device Name: Maximed Exichek TD-4224 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: May 14, 2007 Received: May 18, 2007 Dear Ms. Li: 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) remarket notification. The FDA finding of substantial equivalence of your device to a legally president 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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Jean M. Cooper, M.S., D.V.M. Jean M. Cooper, M.S., 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}------------------------------------------------ ## Indications for Use 510(k) Number: Device Name: Maximed Exichek TD 4224 Blood glucose monitoring system Indications for Use: The Maximed Exichek TD 4224 Blood glucose monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in the Maximed Exichek TD 4224 Blood glucose monitoring system can be used only during steady-state blood glucose conditions. Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (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) ii Carol C. Benson Sign-Off Page 1 of ____________________________________________________________________________________________________________________________________________________________________ ാ of In Vitro Diagnostic Device Firstion and Safety K070239