EASYGLUCO IGM-0002 G2

{0}------------------------------------------------ K0435/2 American HealthCare, Inc. 510(k) for In Vitro Diagnostic Device ### 510(k) SUMMARY (As required by 21.CFR.807.92) | Introduction: | According to the requirements of 21 CFR.807.92, the following<br>information provides sufficient data to understand the basis for a<br>determination of substantial equivalence. | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By: | American HealthCare, Inc.<br>304 Park Avenue South<br>Suite 218<br>New York, NY 10010 | | Contact Person: | Edward Letko<br>Phone: 917-402-5900<br>Fax: 212-202-5173 | | Date Summary,<br>Prepared: | December 14, 2004 | | Device Name: | Propriety Name: EASYGLUCO Blood Glucose Monitoring<br>System<br>Common Name: Blood Glucose Test System<br>Classification Name: Class II, 862.1345 Glucose Blood Tester | | Predicate Device: | We claim substantial equivalence to the LifeScan, Inc.,<br>OneTouch® Ultra®. | | Device<br>Description: | The EASYGLUCO Blood Glucose Monitoring System is an in<br>vitro diagnostic device designed for measuring the concentration of<br>glucose in whole blood, which is used with the EASYGLUCO<br>Test Strips.<br>The test principle is:<br>This device is an in vitro diagnostic product intended for the<br>measurement of glucose concentration in human blood. The<br>principle of the test relies upon a specific type of glucose in the<br>blood sample, the dehydrogenase glucose that reacts to electrodes<br>in the test strip. The test strip employs an electrochemical signal<br>generating an electrical current that will stimulate a chemical<br>reaction. This reaction is measured by the Meter and displayed as<br>your blood glucose result. | | Intended Use: | The EASYGLUCO Blood Glucose Monitoring System is used for<br>the quantitative measurement of glucose level in whole blood as an | | | aid in monitoring the effectiveness of diabetes management in the<br>home and in clinical settings. EASYGLUCO Blood Monitoring<br>System is for testing outside the body (in vitro diagnostic use<br>only). Testing sites include the traditional fingertip testing along<br>with alternate site testing on the arm, palm, thigh and calf. | | Comparison to<br>Predicate Device: | The US Diagnostics, Inc. EASYGLUCO Blood Glucose<br>Monitoring System is substantially equivalent to the other products<br>in commercial distribution intended for similar use. The most<br>notable, it is substantially equivalent to the currently marketed<br>item, the OneTouch® Ultra® by LifeScan, Inc. | | Conclusion: | The EASYGLUCO Blood Glucose Monitoring System is<br>substantially equivalent to the following predicate devices:<br>K024194 – LifeScan, Inc. OneTouch® Ultra®<br>K984261 – LifeScan, Inc. SURESTEP®<br>K021513 – Roche Diagnostics Corp. Accu-Chek Advantage | {1}------------------------------------------------ ### American HealthCare, Inc. 510(k) for In Vitro Diagnostic Device . ## 510(k) Summary, Continued {2}------------------------------------------------ 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 eagle with three stripes forming its wing and tail feathers. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. APR 8 2005 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Edward Letko Managing Director American HealthCare Inc. 304 Park Avenue South Suite 218 New York, NY 10010 Re: k043512 > Trade/Device Name: EASYGLUCO 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: March 9 2005 Received: March 10, 2005 Dear Mr. Letko 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) 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 (240)276-0484. 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/industry/support/index.html Sincerely yours, Jean M. Cooper, MS, DVM Jean 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}------------------------------------------------ # Indications for Use 510(k) Number: k043512 Device Name: EASYGLUCO Blood Glucose Monitoring System Indications For Use: The EASYGLUCO Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The EASYGLUCO Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh, and calf. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (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) Division Sign-off lice of in Vitro Digar Page 1 of