HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM

K113192 · Infopia Co, Ltd. · NBW · Jul 13, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113192
• Device Name: HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Infopia Co, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Healthpro™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The Healthpro™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Healthpro™ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Healthpro™ Blood Glucose Monitoring System should not be used for the diagnosis of 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 Healthpro™ test strips are for use with the Healthpro™ meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The Healthpro™ control solutions are for use with the Healthpro™ meter and test strips to check that the meter and test strips are working together properly and that the test as a quality control checks to verify the accuracy of blood glucose test results.

Device Story

System measures glucose concentration in fresh capillary whole blood via electrical current generated in test strips; meter processes current to provide quantitative glucose reading. Used by patients with diabetes at home for monitoring glycemic control. Includes meter, test strips, and control solutions. Validated for 1,095 cleaning/disinfection cycles using CaviWipes to ensure safety for multi-year use. Output displayed to patient to inform diabetes management decisions.

Clinical Evidence

Clinical study with 150 lay users across three sites compared Healthpro™ results to YSI 2300 reference analyzer. Participants tested samples from seven body sites. Results showed high correlation (r=0.9821) between lay user and YSI measurements. Accuracy met ISO 15197 requirements. Bench testing included precision (CV 1.3-3.5%), linearity (20-600 mg/dL), interference (26 substances tested), hematocrit (20-60%), altitude (up to 10,000 ft), and temperature/humidity stability.

Technological Characteristics

In vitro diagnostic blood glucose monitoring system; glucose oxidase electrochemical sensing principle. Includes meter, test strips, and control solutions. Validated for 1,095 cleaning/disinfection cycles with CaviWipes. Standalone device.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood for single-patient home use by people with diabetes to monitor control effectiveness. Sites: fingertip, ventral palm, dorsal hand, upper arm, forearm, calf, thigh. Contraindications: neonatal use, diabetes screening/diagnosis, critically ill, shock, dehydrated, or hyper-osmolar patients. AST restricted to 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

• GLUCOLAB Auto-coding Blood Glucose Monitoring System (k091157)

Submission Summary (Full Text)

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## 510(k) Summary (k113192)

# JUL 1 3 2012

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

07/09/2012 Date:

#### 1. Submitter:

| Name: | Infopia Co., Ltd<br>891, Hogye-Dong, Dongan-Gu, Anyang,<br>Kyunggi, Republic of Korea 431-080 |
|----------|-----------------------------------------------------------------------------------------------|
| Contact: | Youngju Park<br>Phone [phone]<br>Fax [phone] |

#### 2. Submission Correspondent:

Priscilla Chung LK Consulting Group 951 Starbuck St. Unit J, Fullerton, CA 92833 Phone: [phone] Fax: [phone] Email: [e-mail]

#### 3. Device:

Proprietary Name:

Classification Name:

Common Name:

Healthpro TM Blood Glucose Monitoring System

Name:

System, Test, Blood Glucose, Over The Counter Glucose Oxidase Single(specified) analyte controls

Classification: Classification Product Code: Subsequent Product Codes

Class II, 21 CFR 862.1345 NBW

Blood Glucose Test System

bsequent Product Codes

CGA, JJX

#### Predicate Device: 4.

GLUCOLAB Auto-coding (IGM-0022) Infopia Co., Ltd.

Infopia Co., Ltd.

510k summary Page 1 of 3

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K091157

#### Description: 5.

The Healthpro " Blood Glucose Monitoring System consists of the meter, test strips and control solutions (low, normal and high levels), a lancing device and sterile lancets (sold separately; accessory). The blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

#### ે. Indications for use:

The Healthpro™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, calf and/or thigh. The Healthpro"10 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Healthpro™ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Healthpro™ Blood Glucose Monitoring System should not be used for the diagnosis of 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 Healthpro 104 test strips are for use with the Healthpro " meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The Healthpro " control solutions are for use with the Healthpro "" meter and test strips to check that the meter and test strips are working together properly and that the test as a quality control checks to verify the accuracy of blood glucose test results.

#### 7. Technological Characteristics:

The Healthpro 114 Blood Glucose Monitoring System has the same fundamental scientific technology as the GLUCOLAB Auto-coding (IGM-0022) predicate device, K091157. But the performance characteristic between them shows slight difference.

#### 8. Performance Data:

The Healthpro 101 Blood Glucose Monitoring System was performed in accordance with ISO 15197:2003. The clinical performance evaluation testing included system accuracy, user performance and alternative-site blood glucose measurement. The non-clinical performance evaluations are validated and tested, it conducted to establish the performance, functionality and reliability characteristics of the Healthpro TM Blood Glucose Monitoring System. The device passed all of the tests based on pre-determined Pass/Fail criteria.

510k summary Page 2 of 3

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Disinfectant CaviWipes with the EPA registration number of 46781-8 has been validated demonstrating complete inactivation of live virus of use with the meter and the reusable lancing device. There was also no change in performance or in the external materials of the meter and the lancing device after 1,095 cleaning/disinfection cycles designed to simulate 3 years of device use.

#### . 9. Conclusions:

Infopia Co., Ltd. concludes that the Healthpro™ Blood Glucose Monitoring System is safe and effective also, substantially equivalent to predicate device, GLUCOLAB Auto-coding (IGM-0022), K091157.

510k summary Page 3 of 3

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The seal is black and white.

10903 New Hampshire Avenue Silver Spring, MD 20993

Infopia Co., Ltd. c/o Priscilla Chung Regulatory Affairs Consulting LK Consulting Group 951 Starbuck St. Unit J Fullerton, CA 92833

JUL 1 3 2012

k113192 Re:

RT15172
Trade/Device Name: Healthpro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR, JJX Dated: June 6, 2012 Received: June 7, 2012

Dear Ms. Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bection b 10(t) pennstantially equivalent (for the indications ferenced above and nave determined be arredicate devices marketed in interstate for use stated in the encrosity to regarly manators province Amendments, or to commence prior to May 20, 1970, accordance with the provisions of the Federal Food, devices that have been reclassified in accorequire approval of a premarket approval application Drig, and Cosment Net (Ret) that as he device, subject to the general controls provisions of (FMA). Touring), morelors, manissions of the Act include requirements for annual the Act. The general controls provisions of viewing 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), If your device is Classified (300 a0010) into c. Existing major regulations affecting your device it may be subject to such additional come of Elations (CFR), Parts 800 to 895. In addition, and can be found in Thie 21, Coud of Peaching your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 issualled on a basenantlies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You the Act of any rederal statutes and reguirements, including, but not limited to: registration and must comply with an the Act 3 requirements, and 800); and good manufacturing
Iisting (21 CFR Part 807); labeling (21 CFR Parts 801); maylation (21 CFR Part 82 Ilsting (21 CFR Part 807), labeling (21 CFR Parts 601 million (21 CFR Part 820).

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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/Medical

Devices/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/ResourcesforYou/Industry/default.htm

Sincerely yours,

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices 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 K

Device Name: Healthpro TM Blood Glucose Monitoring System

Indication for use:

The Healthpro 10 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The Healthpro 114 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Healthpro 104 Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Healthpro™ Blood Glucose Monitoring System should not be used for the diagnosis of 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 Healthpro104 test strips are for use with the Healthpro " meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The Healthpro 114 control solutions are for use with the Healthprome meter and test strips to check that the meter and test strips are working together properly and that the test as a quality control checks to verify the accuracy of blood glucose test results.

> Prescription Use_ AND/OR Over-The-Counter Use (Part 21CFR801 Subpart D) (Part 21CFR807 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)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113192

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Infopia Co., Ltd.