EASYGLUCO, MODEL IGM0002

K031501 · American Healthcare, Inc. · NBW · Oct 16, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031501
• Device Name: EASYGLUCO, MODEL IGM0002
• Applicant: American Healthcare, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The EASYGLUCO™ Monitoring System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.

Device Story

EASYGLUCO™ Monitor is an in vitro diagnostic device for quantitative whole blood glucose measurement. System uses EASYGLUCO™ Test Strips; glucose dehydrogenase in blood sample reacts with electrodes on strip; electrochemical signal generates electrical current proportional to glucose concentration. Meter measures current; displays result to user. Used by individuals with diabetes in home settings or by clinicians in clinical settings. Output provides glucose concentration data to assist in diabetes management.

Clinical Evidence

Bench testing included within-run and day-to-day precision (CVs 2.2-4.8%), linearity (R²=0.9991), and interference testing per NCCLS EP-7. Method comparison study performed on 416 blood samples (clinical centers) and 104 capillary samples (diabetic patients) against Hitachi 747 analyzer. Results showed high correlation (r=0.979 and r=0.978 respectively). No clinical sensitivity/specificity studies performed as device is an in vitro diagnostic glucose monitor.

Technological Characteristics

In vitro diagnostic blood glucose monitor; electrochemical sensing principle using glucose dehydrogenase; utilizes test strips; Class II device (21 CFR 862.1345).

Indications for Use

Indicated for individuals with diabetes for quantitative measurement of whole blood glucose levels to monitor diabetes management in home and clinical settings.

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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OCT 1 6 2003

American HealthCare, Inc. 510(k) for In Vitro Diagnostic Device

K031501

# 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 206<br>New York, NY 10010 |
| Contact Person: | Edward Letko<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary,<br>Prepared: | April 18, 2003 |
| Device Name: | Propriety Name: EASYGLUCO™<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. |
| | 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™ Monitoring System is used by individuals<br>with diabetes. It is for the quantitative measurement of glucose<br>levels in whole blood, as an aid in monitoring the effectiveness of<br>diabetes management in the home and in clinical settings. |
| Comparison to<br>Predicate Device: | The Infopia Co., Ltd. EASYGLUCO™ Module is substantially<br>equivalent to the other products in commercial distribution<br>intended for similar use. The most notable, it is substantially<br>equivalent to the currently marketed item, the OneTouch® Ultra®<br>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 |

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#### American HealthCare, Inc.

510(k) for In Vitro Diagnostic Device

# 510(k) Summary, Continued

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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OCT 1 6 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Edward Letko Managing Director American HealthCare, Inc. 304 Park Avenue South - Suite 206 New York, NY 10010

Re: k031501 Trade/Device Name: EASYGLUCO™ Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW; CGA; JJX Dated: September 8, 2003 Received: September 9, 2003

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).

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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 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K 03 1501

Device Name: EASYGLUCO™

- Indications For Use: The EASYGLUCO™ Monitoring System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.
Carol C Benam fo Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031501

X OTC use