EASYGLUCO, MODEL IGM-0002 G2

K061431 · U. S. Diagnostics, Inc. · CGA · Jan 12, 2007 · Clinical Chemistry

Device Facts

• Record ID: K061431
• Device Name: EASYGLUCO, MODEL IGM-0002 G2
• Applicant: U. S. Diagnostics, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EASYGLUCO™ Diabetes 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. EASYGLUCO™ System is for testing outside the body (in vitro diagnostic use only). The EASYGLUCO Diabetes Monitoring System is not for use with neonatal blood specimens. Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, palm, calf and thigh.

Device Story

EASYGLUCO™ G2 is an in vitro diagnostic blood glucose monitoring system. Device utilizes disposable test strips containing electrodes; whole blood sample applied to strip; electrochemical reaction occurs between blood glucose (dehydrogenase glucose) and strip electrodes. Meter measures resulting electrical current; converts current to glucose concentration; displays result to user. Used in home or clinical settings by patients or healthcare providers. Provides quantitative glucose data to assist in diabetes management; enables monitoring of treatment effectiveness.

Clinical Evidence

No clinical data provided in the summary. Substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Electrochemical glucose monitoring system. Uses dehydrogenase glucose-based test strips. Measures electrical current generated by chemical reaction. Form factor: handheld meter. Connectivity: not specified. Sterilization: not specified.

Indications for Use

Indicated for quantitative blood glucose monitoring in patients with diabetes in home and clinical settings. Not for neonatal use. Supports fingertip and alternate site testing (arm, palm, calf, thigh).

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• OneTouch® Ultra® (K024194)
• SURESTEP® (K984261)
• Accu-Chek Advantage (K021513)

Submission Summary (Full Text)

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K061431

IAN 1 2 2007

| 510(k) SUMMARY<br>(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: | US Diagnostics, Inc.<br>304 Park Avenue South<br>Suite 218<br>New York, NY 10010 |
| Contact Person: | Edward Letko<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary,<br>Prepared: | October 5, 2006 |
| Device Name: | Propriety Name: EASYGLUCO™ G2<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™ Monitor is an in vitro diagnostic device<br>designed for measuring the concentration of glucose in whole<br>blood, which is used with the EASYGLUCO™ 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 signalgenerating 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™ Diabetes Monitoring System is used for the<br>quantitative measurement of glucose level in whole blood as an aid<br>in monitoring the effectiveness of diabetes management in the<br>home and in clinical settings. EASYGLUCO™ System is for |
| 510(k) Summary, Continued | |
| | testing outside the body (in vitro diagnostic use only). The<br>EASYGLUCO Diabetes Monitoring System is not for use with<br>neonatal blood specimens. Testing sites include the traditional<br>fingertip testing along with alternate site testing on the forearm,<br>palm, calf and thigh. |
| Comparison to<br>Predicate Device: | The US Diagnostics, Inc.. EASYGLUCOTM G2 Module is<br>substantially equivalent to the other products in commercial<br>distribution intended for similar use. The most notable, it is<br>substantially equivalent to the currently marketed item, the<br>OneTouch® Ultra® by LifeScan, Inc. |
| Conclusion: | The EASYGLUCOTM G2 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 |

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## US Diagnostics, Inc. 510(k) for In Vitro Diagnostic Device

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle emblem. The logo is presented in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Edward Letko Managing Director US Diagnostics, Inc. 304 Park Avenue South, Suite 218 New York, NY 10010-4301

Re: k061431

Trade/Device Name: EASYGLUCO G2 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Blood Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: December 4, 2006 Received: December 5, 2006

JAN 1 2 2007

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 1 vire, 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).

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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 1egally 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 [phone]. Also, please ontre 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 the [phone] or [phone] 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.

Yean 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

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## Indications for Use

510(k) Number:

Device Name: EASYGLUCOTM

Indications For Use: The EASYGLUCO™ Diabetes 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. EASYGLUCO™ System is for testing outside the body (in vitro diagnostic use only). The EASYGLUCO Diabetes Monitoring System is not for use with neonatal blood specimens. Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, calf and thigh.

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)

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Carl Benson
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Office of In Vitro Diagnostic Device Evaluation and Safety

K06143/

Confidential American HealthCare, Inc.