GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025

K091168 · Infopia Co, Ltd. · NBW · May 27, 2010 · Clinical Chemistry

Device Facts

• Record ID: K091168
• Device Name: GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025
• Applicant: Infopia Co, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Glucophone™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or healthcare professionals in the home and in clinical setting. Glucophone™ Blood Glucose Testing System is for testing outside the body (in vitro diagnostic use only). GlucoPhone™ Blood glucose Testing system is for use with a cellular phone.

Device Story

Glucophone™ integrates blood glucose meter with Motorola v3 cellular phone; measures glucose in capillary whole blood via test strips. Principle: glucose oxidase on test strip reacts with blood sample; electrochemical signal generated; meter measures current; result displayed on phone. Used by patients or clinicians in home/clinical settings. Output informs glucose management; aids diabetic patients in monitoring levels. Device leverages existing meter/strip technology from predicate systems.

Clinical Evidence

Clinical performance evaluation conducted to validate consumer use and professional accuracy. Results demonstrated substantial equivalence to predicate devices. Non-clinical testing included verification and validation of software, product, and user interface requirements per risk analysis; device passed all pre-determined pass/fail criteria.

Technological Characteristics

Electrochemical glucose oxidase biosensor; capillary whole blood input; integrated with Motorola v3 cellular phone. Meter technology derived from GlucoPack™; strip technology derived from GlucoLab™. Standalone test system functionality.

Indications for Use

Indicated for quantitative blood glucose measurement in diabetic patients or healthcare professionals. Not for neonatal use, not for diagnosis or screening of diabetes. Contraindicated for patients in shock, hypotensive, hyperglycemic, or hyperosmolar states (with/without ketosis). Alternate site testing indicated only during steady-state 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

• GlucoPack™ Blood Glucose Monitoring System (k052469)

Submission Summary (Full Text)

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inopia co.,ku Blood Glucose monitoring system
510(k) for In Vitro Diagnostic Device

510(k) Summary

Attachment #4

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. The assigned 510(K) Number is not applicable.

Date: May 21, 2010

MAY 2 7 2010

1091168

# 1. Submitter:

| Submitted by: | Infopia Co.,ltd.<br>#891, Hogye-dong, Dongan-Gu<br>Anyang, Kyunggi<br>431-080, Korea<br>Phone: [phone]<br>Fax: [phone] |
|---------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Bryan Oh<br>Phone: [phone]<br>Fax: [phone] |

#### 2. Device:

| Propriety Name | Glucophone™ Blood Glucose Monitoring System |
|----------------------|--------------------------------------------------------|
| Common Name | Blood Glucose Test System |
| Classification Name: | Glucose Oxidase<br>Single (specified) analyte controls |
| Classification: | Class II, 21 CFR 862.1345, |
| Product Code: | NBW, CGA, JJX |

#### 3. Predicate Device:

GlucoPack™ Blood Glucose Monitoring System(HealthPia America Corp.) K052469 GlucoLab™ Blood Glucose Monitoring System(Infopia co., Ltd.) K051285

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#### Description: 4.

The Glucophone™ Meter device combined with Cell Phone (Motorola v3) is used along with the Glucophone The Test Strip to measure the glucose level in capillary whole blood.

# Test Principle

The principle of the test relies upon a specific type of glucose in the blood sample, the glucose oxidase 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.

### 5. Indications for use:

Glucophone™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or healthcare professionals in the home and in clinical setting. Glucophone™ Blood Glucose Testing System is for testing outside the body (in vitro diagnostic use only). GlucoPhone™ Blood glucose Testing system is for use with a cellular phone. GlucoPhone™ Blood glucose Testing system is not for neonatal use and not for diagnosis or screening of diabetes. Alternate site testing is for use during times of steady state.

# Comparison of Technological Characteristics with Predicate: 6.

The technological characteristics of the new device (Glucophone™) in comparison to two predicate devices (GlucoPack™, GlucoLab™):

The modified Glucophone™ device has the same technological characteristics as the current legally marketed predicate devices: 1. same in the meter device technology with GlucoPack™ Glucose Monitoring System (K052469) By HealthPia America Corp. and 2. same in the strip technology with GlucoLab™ Blood Glucose Monitoring System (K051285) By Infopia co., Ltd..

# 7. Performance Data:

Clinical: The clinical performance evaluation using the Glucophone™ Blood Glucose Monitoring System components were conducted for the purpose of validating consumer use and professional accuracy. Test results showed substantial equivalence.

Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the Glucophone "" Blood Glucose Monitoring System with respect to two predicate devices. Testing involved the verification

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of software requirement specifications, product requirement specifications and user interface requirement specifications from the risk analysis. The device passed all of the tests based on pre-determined Pass/Fail criteria.

#### 8. Conclusion

The data from the clinical and non clinical tests show that the Glucophone™ Blood Glucose Monitoring System is as safe and effective as the legally marketed predicate devices, the GlucoPack™ and GlucoLab™

Therefore we conclude that the Glucophone™ Blood Glucose Monitoring System is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

MAY 2 7 200

Infopia Co., Ltd. C/O Maria Griffin MDI Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021

Re: k091168

Trade/Device Name: Glucophone™ Blood Glucose Testing System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: May 21, 2010 Received: May 24, 2010

Dear Ms. Griffin:

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. 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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

AC

Courtney C. Harper, Ph.D. 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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# Indication for Use

510(k) Number (if known): K091168

Device Name: Glucophone™ Blood Glucose Testing System

Indication For Use:

Glucophone™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or healthcare professionals in the home and in clinical setting. Glucophone™ Blood Glucose Testing System is for testing outside the body (in vitro diagnostic use only). GlucoPhone™ Blood glucose Testing system is for use with a cellular phone. GlucoPhone™ Blood glucose Testing system is not for neonatal use and not for diagnosis or screening of diabetes. Alternate site testing is for use during times of steady state.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X . (21 CFR Part 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol Benain

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)