ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM

K133045 · Infopia Co, Ltd. · NBW · Apr 10, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133045
• Device Name: ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Infopia Co, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Element™ Lite Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Element™ Lite Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Element™ Lite 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 Element™ Lite Test Strips are for use with the Element™ Lite Meter to quantitatively measure glucose 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 Element™ Lite Control Solutions are for use with the Element™ Lite Meter and Element™ Lite Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

Device Story

System measures glucose concentration in fresh capillary whole blood; utilizes electrical current generated in test strip; meter processes current to provide quantitative glucose reading. Used at home by patients with diabetes to monitor glycemic control. Includes meter, test strips, control solutions, lancing device, and lancets. Healthcare providers review results to assess diabetes management effectiveness. Benefits include convenient, rapid self-monitoring of blood glucose levels.

Clinical Evidence

User performance study conducted at three clinical sites with 150-170 participants. Compared lay user results from multiple sites (fingertip, palm, hand, arm, forearm, calf, thigh) against YSI 2300 reference method. Results showed 100% of samples within ±20% of reference for glucose ≥75 mg/dL across all sites. Precision studies (within-run and intermediate) demonstrated %CV between 1.4% and 3.7%.

Technological Characteristics

Amperometric glucose oxidase biosensor. Dimensions: 54x82x18mm; Weight: 41g. Power: two 3.0V CR2032 lithium batteries. Connectivity: wired data transfer to GlucoDiary system. Auto-coding via strip circuit. Operating range: 50-104°F, 10-90% RH. Traceable to NIST SRM 917b.

Indications for Use

Indicated for quantitative blood glucose measurement in people with diabetes. For home use by a single patient. Samples: fresh capillary whole blood from fingertips, ventral palm, dorsal hand, upper arm, forearm, calf, and thigh. Contraindications: not for diagnosis or screening of diabetes; not for neonatal use; alternative site testing 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

• Element™ Blood Glucose Monitoring System (K113670)

Submission Summary (Full Text)

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K133045

## 510(k) Summary

# APR 1 0 2014

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

Date: ___ 03/13/2014

#### 1. Submission Applicant:

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

Phone [phone] Fax [phone]

#### 2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92833 Phone: [phone] Fax: [phone] Email: [e-mail]

#### 3. Device: ·

- Device's Trade Name:
Element™ Lite Blood Glucose Monitoring System

■ Device's Common Name:

■ Device's Classification Name:

Blood Glucose Test System Quality control material (assayed and unassayed)

Glucose oxidase, glucose Single (specified) analyte controls Calculator/data processing module for clinical use

■ Classification Regulation:

- Classification Product Code:
21CFR 862.1345 21CFR 862.1660

CGA, NBW, JJX

Infopia Co., Ltd.

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#### 4. Predicate Device:

Element™ Blood Glucose Monitoring System (K113670) by Infopia Co., Ltd.

#### 5. Description:

The Element™ Lite 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. 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:

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

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

#### 7. Technological Characteristics:

The Element™ Lite Blood Glucose Monitoring System has the same fundamental scientific technology as the predicate device and has similar performance specifications and features.

#### 8. Performance Data:

The performance tests for the Element™ Lite Blood Glucose Monitoring System were performed in accordance with ISO 15197:2003 and some other international standards. Clinical evaluation included method 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 Element™ Lite Blood Glucose Monitoring System. The device passed all of the tests based on predetermined Pass/Fail criteria.

.

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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 1,098 cleaning/disinfection cycles designed to simulate 3 years of device use.

#### 9. Conclusion:

Infopia Co., Ltd. concludes that the Element™ Lite Blood Glucose Monitoring System is safe and effective and also substantially equivalent to the predicate device, Element™ Blood Glucose Monitoring System (K113670).

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K133045

#### Device Name

Element™ Lite Blood Glucose Monitoring System

Indications for Use (Describe)

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

The Element™ Lite 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 Element™ Lite Test Strips are for use with the Element™ Lite Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand thigh.

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

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 10, 2014

## INFOPIA CO., LTD. C/O PRISCILLA CHUNG 2651 E. CHAPMAN AVE STE. 110 FULLERTON CA 92831

Re: K133045

Trade/Device Name: Element™ Lite Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: September 24, 2013 Received: September 27, 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 Parts 801 and 809); 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.

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Page 2-Ms. Priscilla Chung

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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.

Courtney H. Lias -S

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

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

### 510(k) Number (if known) K133045

### Device Name

Element™ Lite Blood Glucose Monitoring System

### Indications for Use (Describe)

The Element™ Lite Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingerips, ventral pain, dorearn, calf and thigh. The Element™ Life Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Element™ Lite Blood Glucose Monitoring System is intended the body (in viro diagnostic use) by people with diabeles at home as an aid to monitor the effectiveness of diabetes control. It should not be used for screening of diabeles or for neonatal use. Alternative should be done only during steady-state times (when glucose is not changing rapidly).

The Element™ Lite Test Strips are for use with the Element™ Lite Meter to quantitatively measure glacese in fresh capillary whole blood. Fresh capillary whole blood samples may be fingertips, ventral palm, dorsal hand, upper arm, forcarn, calf and thigh.

The Element™ Lite Control Solutions are for use with the Element™ Lite Test Strips to check (trat the meter and test strips are working together properly and the test is performing correctly.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

. FOR FDA USE ONLY

currence of Center for Devices and Radiological Health (CDRH) (Signature)