GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM

K130181 · Infopia Co, Ltd. · NBW · Jul 31, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130181
• Device Name: GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Infopia Co, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GluNEO™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The GluNEO™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The GluNEO™ Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It 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 GluNEO™ Test Strips are for use with the GluNEO™ Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The GluNEO™ Control Solutions are for use with the GluNEO™ Meter and GluNEO™ Test Strips to check that the meter and test strips are working together properly and the test is performing correctly. The GlucoDiary is a PC-based software intended for use in home to help people with diabetes in the review, analysis and evaluation of glucose test results for effective diabetes management. It is intended for use as an accessory to GluNEO™ Blood Glucose Monitoring System. The GluNEO™ Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The GluNEO™ Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use landing devices. The GluNEO™ Professional 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 GluNEO™ Professional Test Strips are for use with the GluNEO™ Professional Meter to quantitatively measure glucose (sugar) in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The GluNEO™ Professional Control Solutions are for use with the GluNEO™ Professional Meter and GluNEO™ Professional Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. The GlucoDiary is a PC-based software intended for use in professional settings to help healthcare professionals in the review, analysis and evaluation of their patients' glucose test results for effective diabetes management. It is intended for use as an accessory to GluNEO™ Professional Blood Glucose Monitoring System.

Device Story

System measures glucose concentration in whole blood samples via electrical current generated in test strips. Meter processes current to provide quantitative glucose reading. Used by patients at home or healthcare professionals in clinical settings. Includes GlucoDiary PC software for review, analysis, and evaluation of test results to aid diabetes management. Professional version requires auto-disabling, single-use lancing devices. System includes meter, test strips, control solutions, and lancing accessories. Provides immediate feedback to users/clinicians for monitoring diabetes control effectiveness.

Clinical Evidence

Clinical performance evaluated via method comparison studies (n=150 lay users, n=100 professional samples) against YSI 2300 reference. Accuracy assessed across capillary and venous samples; results showed 100% of samples within ±20% of reference for glucose ≥75 mg/dL. Precision studies (repeatability/intermediate) showed CVs ranging from 1.3% to 3.5%. No clinical sensitivity/specificity data required for this assay type.

Technological Characteristics

In vitro diagnostic blood glucose monitoring system. Uses electrical current sensing principle. Includes meter, test strips, control solutions, and PC-based software. Validated for 10,980 cleaning/disinfection cycles using Cavi Wipes (EPA Reg 46781-8).

Indications for Use

Indicated for people with diabetes to monitor glucose levels in fresh capillary whole blood (fingertips, palm, forearm, upper arm, calf, thigh) or venous whole blood (professional version). Contraindicated for neonatal use, diagnosis/screening of diabetes, critically ill patients, patients in shock, dehydrated patients, or hyper-osmolar patients.

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

• Ascensia® CONTOUR® Blood Glucose Monitoring System (k062058)

Submission Summary (Full Text)

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

# 510(k) Summary

K130181

JUL 3 1 2013

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

Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: 07/18/2013

### 1. Applicant / Submitter:

Infopia Co., Ltd. 891, Hogye-Dong, Dongan-Gu, Anyang, Kyunggi, Republic of Korea 431-080

Contact: Sunmi Shin Phone [phone] Fax [phone]

#### 2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 1515 E Katella Ave Unit 2115, Anaheim. CA 92805. Phone: [phone] Fax: [phone] Email: [e-mail]

#### 3. Device:

| ■ Device's Trade Name: | GluNEO™ Glucose Monitoring System<br>GluNEO™ Professional Glucose Monitoring<br>System |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| ■ Device's Common Name: | Blood Glucose Test System<br>Quality control material (assayed and<br>unassayed) |
| ■ Device's Classification Name: | Glucose Dehydrogenase<br>Single (specified) analyte controls<br>Calculator/data processing module for clinical<br>use |
| ■ Classification Regulation: | 21CFR 862.1345<br>21CFR 862.1660<br>21CFR 862.2100 |
| ■ Classification Product Code: | LFR, NBW, JJX, JQP |

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

### 4. Predicate Device:

Ascensia CONTOUR® Blood Glucose Monitoring System (K062058) by Bayer HealthCare, LLC.

### 5. Description:

The GluNEOTM Blood Glucose Monitoring System consists of a meter, test strips and control solutions (level 1, level 2 and level 3), a lancing device and sterile lancets. With GluNEO™ Professional Blood Glucose Monitoring System, only auto-disabling or single use lancing device must be used.

This 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.

### 6. Indications for use:

### . GluNEOTM Blood Glucose Monitoring System

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

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

The GluNEO™ Test Strips are for use with the GluNEO™ Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The GluNEO™ Control Solutions are for use with the GluNEO™ Meter and GluNEO™ Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

The GlucoDiary is a PC-based software intended for use in home to help people with diabetes in the review, analysis and evaluation of glucose test results for effective diabetes management. It is intended for use as an accessory to GluNEO™ Blood Glucose Monitoring System.

### ▪ GluNEO™ Professional Blood Glucose Monitoring System

The GluNEO™ Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The

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

GluNEO™ Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The GluNEO™ Professional 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 GluNEO™ Professional Test Strips are for use with the GluNEO™ Professional Meter to quantitatively measure glucose (sugar) in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm. forearm, calf and/or thigh.

The GluNEO™ Professional Control Solutions are for use with the GluNEO™ Professional Meter and GluNEO™ Professional Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The GlucoDiary is a PC-based software intended for use in professional settings to help healthcare professionals in the review, analysis and evaluation of their patients' glucose test results for effective diabetes management. It is intended for use as an accessory to GluNEOTM Professional Blood Glucose Monitoring System.

### 7. Technological Characteristics:

The GluNEO™ / GluNEO™ Professional Blood Glucose Monitoring System has the same fundamental scientific technology as Ascensia® CONTOUR® Blood Glucose Monitoring System (K062508), and has similar performance specifications and features.

### 8. Performance Data:

The performance tests for the GluNEOTM / GluNEOTM Professional Blood Glucose Monitoring System were performed in accordance with ISO 15197:2003. Clinical evaluation included method comparison, matrix comparison, user performance and alternative-site blood glucose measurement. Non-clinical performance evaluations were conducted to establish the performance, functionality and reliability characteristics of the GluNEO"™ / GluNEOTM Professional Blood Glucose Monitoring System. The device passed all of the tests based on pre-determined Pass/Fail criteria.

Disinfectant Cavi Wipes 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 10,980 cleaning/disinfection cycles designed to simulate 3 years of device use.

### 9. Conclusions:

Infopia Co., Ltd. concludes that the GluNEOTM / GluNEOT™ Professional Blood Glucose Monitoring System is safe and effective also, substantially equivalent to the predicate device. Ascensia® CONTOUR® Blood Glucose Monitoring System (K062058) by Bayer HealthCare, LLC.

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

Ascensia® CONTOUR® Blood Glucose Monitoring System (K062058) by Bayer HealthCare, LLC.

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

Public Health Service

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

July 31, 2013

Infopia Co., Ltd. C/O Priscilla Chung LK Consulting Group USA, Inc. 951 Starbuck St. Unit J FULLERTON CA 92833

Re: K130181

Trade/Device Name: GluNEO™ Blood Glucose Monitoring System GluNEO™ Professional Blood Glucose Monitoring System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JQP, JJX Dated: June 24, 2013 Received: July 2, 2013

Dear Ms. Chung:

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.

{5}------------------------------------------------

Page 2-Ms. Chung

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOfTiccs/CDRH0ffices/ucm115809.html for 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/McdicalDevices/Safety/Reportal?roblem/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.

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

{6}------------------------------------------------

## Indications for Use

510(k) Number K 130181

Device Name: GluNEOTM Blood Glucose Monitoring System

Indication for use:

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

The GluNEO™ Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It 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 GluNEO™ Test Strips are for use with the GluNEO™ Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The GluNEO™ Control Solutions are for use with the GluNEO™ Meter and GluNEO™ Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

The GlucoDiary is a PC-based software intended for use in home to help people with diabetes in the review, analysis and evaluation of glucose test results for effective diabetes management. It is intended for use as an accessory to GluNEO™ Blood Glucose Monitoring System.

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

Katherine Serrano -S

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

510(k) k130181

Infopia Co., Ltd.

{7}------------------------------------------------

## Indications for Use

510(k) Number K 130181

Device Name: GluNEO™ Professional Blood Glucose Monitoring System

Indication for use:

The GluNEO™ Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The GluNEO™ Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The GluNEO™ Professional 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 GluNEO™ Professional Test Strips are for use with the GluNEO™ Professional Meter to quantitatively measure glucose (sugar) in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

The GluNEO™ Professional Control Solutions are for use with the GluNEO™ Professional Meter and GluNEO™ Professional Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

The GlucoDiary is a PC-based software intended for use in professional settings to help healthcare professionals in the review, analysis and evaluation of their patients' glucose test results for effective diabetes management. It is intended for use as an accessory to GluNEO™ Professional Blood Glucose Monitoring System.

> 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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro and Radiological Health (OIR)

# Katherine Serrano -S

Division Sign-Off Office of In Vitro and Radiological Health Evaluation and Safety

510(k) k130181

Infopia Co., Ltd.