BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)

K113636 · Philosys Co., Ltd. · CGA · Mar 8, 2013 · Clinical Chemistry

Device Facts

• Record ID: K113636
• Device Name: BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
• Applicant: Philosys Co., Ltd.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Mar 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Gmate® VOICE™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by individuals with diabetes. The Gmate® VOICE™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared with any other person. The Gmate® VOICE™ Blood Glucose Monitoring System is for self testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Gmate® VOICE™ Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The Gmate® VOICE Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users. The Gmate® Blood Glucose Test Strips are for use with the Gmate® VOICE™ Blood Glucose Monitoring System for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, hand, upper arm, forearm, calf or thigh. The Gmate® Control Solution is for use with the Gmate® VOICE Blood Glucose Monitoring System and is intended as a quality control measure to verify the accuracy of your blood glucose test results and to ensure that the Gmate® VOICE meter and Gmate® Test Strips are working properly. The Gmate® Control Solution is intended for use by people with diabetes at home.

Device Story

Gmate VOICE is a portable blood glucose monitoring system for home use by diabetic patients; includes a speaking feature for audible results. Input: 0.5 μL fresh capillary whole blood applied to a test strip. Operation: Amperometric measurement of electrical current generated by glucose oxidation (glucose oxidase enzyme/potassium ferricyanide mediator) on a carbon electrode. Output: Quantitative glucose concentration (20-600 mg/dL) displayed on screen and announced via voice. Used by patients for self-monitoring; aids in diabetes management decisions. System includes meter, test strips, lancing device, and control solutions. Data can be transferred to a computer via USART interface for management software analysis. Benefits: Provides accessible, audible glucose readings for visually impaired users; supports frequent monitoring to track glycemic control.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrochemical glucose monitoring system. Uses glucose oxidase-based test strips. Meter provides digital display and audible voice output. Designed for home use. In vitro diagnostic device.

Indications for Use

Indicated for quantitative blood glucose measurement in fresh capillary whole blood (fingertip, hand, upper arm, forearm, calf, thigh) to monitor diabetes management effectiveness in home settings. For single-user, self-testing only. Contraindicated for diabetes diagnosis, screening, or neonatal use. Alternative site testing restricted to steady-state glucose conditions.

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® System (k002134)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Philosys, Inc. The logo consists of a stylized graphic to the left of the company name. The company name is written in a bold, sans-serif font.

New York Office 304 Park Avenue South, Suite 218 New York, NY 10010 USA TEL: 855-GO-GMATE FAX: [phone]

K113636

MAR

8 2013

Seoul Office 635-5 Yeoksam-dong, Kangnam-ku, Seoul, 135-908, Korea TEL: [phone] FAX: [phone]

510(k) SUMMARY (As required by 21.CFR.807.92)

ﺮ"

| Introduction: | According to the requirements of 21 CFR.807.92, the following information provides sufficient data to understand the basis. for a determination of substantial equivalence. |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Philosys Co Ltd<br>304 Park Avenue South<br>Suite 218<br>New York, NY 10010 |
| Contact Person: | Linda Chan<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary, Prepared: | December 8, 2011 |
| Device Name: | Propriety Name: Gmate® VOICE Blood Glucose Monitoring System and Ch<br>Common Name: Blood Glucose Test System<br>Classification Name: Class II, 862.1345 Blood Glucose Monitoring System<br>Product Code:<br>CGA - Glucose Oxidase, Glucose<br>NBW - System, Test, Blood Glucose, Over the Counter |
| | Propriety Name: Gmate® Control Solution<br>Classification Name: Class I, 21 CFR 862.1660, Quality Control Material (assayed and unassayed)<br>Product Code:<br>JJX - Single Analyte Controls (assayed and unassayed) |
| Predicate Device: | We claim substantial equivalence to the OneTouch® ULTRA® System Manufactured by LifeScan, Inc., K002134. |
| Device Description: | The Gmate® VOICE Blood Glucose Monitoring System is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the Gmate® Blood Glucose Test Strips. |

The test principle is:

This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the glucose oxidase that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

{1}------------------------------------------------

New York Office 304 Park Avenue South, Suite 218 New York, NY 10010 USA TEL: 855-GO-GMATE FAX: [phone]

Seoul Office 635-5 Yeoksam-dong, Kangnam-ku, Seoul, 135-908, Korea TEL: [phone] FAX: [phone]

## 510(k) SUMMARY (As required by 21.CFR.807.92)

Intended Use:

The Gmate® VOICE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by individuals with diabetes. The Gmate® VOICE Blood Glucose Monitoring

System is intended to be used by a single user and should not be shared with any other person.

Gmate® VOICE Blood Glucose Monitoring System is for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Gmate® VOICE Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Gmate® VOICE Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users.

The Gmate® Blood Glucose Test Strips are for use with the Gmate® VOICE Meter for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, hand, upper arm, forearm, calf or thigh.

The Gmate® Control Solution is for use with the Gmate® VOICE Blood Glucose Monitoring System and is intended as a quality control measure to verify the accuracy of your blood glucose test results and to ensure that the Gmate® VOICE meter and Gmate® Test Strips are working properly. The Gmate® Control Solution is intended for use by people with diabetes at home.

| Comparison to<br>Predicate Device: | The Gmate® VOICE Blood Glucose Monitoring System is substantially<br>equivalent to the other products in commercial distribution intended for<br>similar use. The most notable, it is substantially equivalent to the currently<br>marketed item, OneTouch® ULTRA® System Manufactured by LifeScan, Inc.,<br>K002134. |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The Gmate® VOICE Blood Glucose Monitoring System is substantially<br>equivalent to the following predicate device:<br>OneTouch® ULTRA® System Manufactured by LifeScan, Inc., K002134. |

{2}------------------------------------------------

# 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms, composed of three curved lines.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

# March 8, 2013

Philosys. Inc. C/O Linda Chan 304 Park Avenue South, Suite 218 New York, NY 10010

Re: k113636

Trade/Device Name: Gmate VOICE™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, NBW, JJX Dated: February 14, 2013 Received: February 15, 2013

Dear Ms. Chan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for

{3}------------------------------------------------

Page 2-Ms. Chan

the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol G. Benson -S for

Courtney H. Lias, Ph.D.

Director

Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics

and Radiological Health Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K113636

Gmate® VOICE Blood Glucose Monitoring System Device Name:

Indications for Use:

The Gmate® VOICE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingerting, hand, upper ann, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes magagement in the home by individuals with diabetes. The Gmate® VOICE Blood Glucose Monitoring System is intented to be used by a single user and should not be shared with any other person.

The Gmate® VOICE Blood Glucose Monitoring System is for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of diabels control. The Gmate® VOICE Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-ste times (when glucose is not changing rapidly).

The Cmate® VOICE Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users.

The Gmate® Blood Glucose Test Strips are for use with the Gmate® VOICE Meter for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fine grannumment upper arm, forearm, calf or thigh.

The Gmate® Control Solution is for use with the Gmate® VOICE Blood Glucose Monitoring System and is intended as a quality control measure to verify the accuracy of your blood glucose test results and to ensure that the Gmate® VOICE meter and Gmate® Test Strips are working properly. The Gmate® and to Control Solution is intended for use by people with diabetes at home.

> Prescription Use AND/OR Over-The-Counter Use__X (Part 21 CFR 801 Subpart D) (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

# Kathering Serrano

Division Sign-Off Office of In Vitro Diagnostic and Radiological Health

510(k) k113636