BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM

K113077 · Taidoc Technology Corporation · NBW · Aug 3, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113077
• Device Name: BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Bioland G-423 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. This system is intended to be used by a single person and should not be shared. The Bioland G-423 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 Bioland G-423 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The Bioland G-423 Test Strips are for use with the Bioland G-423 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Device Story

System consists of a blood glucose meter and test strips; utilizes electrochemical biosensor technology with glucose oxidase (A. Niger) to measure glucose in fresh capillary whole blood samples. Operated by patients at home for self-monitoring of diabetes control. User applies blood sample to test strip inserted into meter; device performs quantitative measurement; displays result to user. Output assists patients in tracking diabetes management effectiveness. System is intended for single-person use.

Clinical Evidence

Clinical accuracy study conducted with 182 lay-users and trained operators. Samples ranged 35-578 mg/dL. Results met ISO 15197:2003 criteria: 95% of results within ±15 mg/dL (at <75 mg/dL) or ±20% (at ≥75 mg/dL) of YSI reference values. Precision studies (repeatability and intermediate) showed CVs < 3.5%. Linearity verified across 15-621 mg/dL range (r² > 0.99).

Technological Characteristics

Electrochemical biosensor using glucose oxidase (A. Niger). System comprises a meter and test strips. Validated for accuracy, precision, and environmental interference (hematocrit, altitude).

Indications for Use

Indicated for self-testing of blood glucose levels in people with diabetes using fresh capillary whole blood from fingertips. Not for neonatal use, diagnosis, or screening of diabetes. Single-patient use only.

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

• Prodigy Blood Glucose System (k053593)

Submission Summary (Full Text)

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#### 510(k) Summary 3.

# AUG

3 2012

# 510(K) SUMMARY

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

The Assigned 510(k) number is: 长川3077

- 1. Submitter's Identification: BIOLAND TECHNOLOGY LTD. Room 1122, 11/F., Liven House, 61-63 King Yip Street, Kwun Tong, Kowloon, Hong Kong, China
Córrespondence: Teling Hsu Tel: [phone] #1176 Fax: [phone] Email: [e-mail]

Date of preparation: October 14, 2011

- 2. Device name:
Proprietary name: BIOLAND G-423 BLOOD GLUCOSE MONITORING SYSTEM, MODEL G-423

Regulatory information:

- Regulation section: 21 CFR § 862.1345, Glucose Test System A.
- Class II (Glucose Test System) B. Classification:
- CGA, Glucose Oxidase, Glucose Product Code: C..

NBW, System, Test, Blood Glucose, Over The Counter

- 75, Clinical Chemistry Glucose Test System Panel: D.

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## 3. Intended Use:

The Bioland G-423 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. This system is intended to be used by a single person and should not be shared.

The Bioland G-423 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 Bioland G-423 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

The Bioland G-423 Test Strips are for use with the Bioland G-423 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

- 4. Device Description:
The kit of BIOLAND G-423 BLOOD GLUCOSE MONITORING SYSTEM MODEL G-423 consist of: the meter with blood glucose measurement function and test strips. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.

- 5. Substantial Equivalence Information:
Predicate device name: Prodigy Blood Glucose System A.

Predicate K number: k053593

- B. Comparison with predicate:
The BIOLAND G-423 BLOOD GLUCOSE MONITORING SYSTEM MODEL G-423 has the following similarities to the predicate device:

- same operating principle,
- same fundamental scientific technology,
- incorporate the same basic circuit design,
- incorporate the same materials,
- same shelf life
- . packaged using the same materials, and
- manufactured by the same process. .

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The differences encompass:

- Software 월
- 트 Physical appearance
- User interface 배
- Labeling .
- 6. Test Principle:

For blood glucose, the detection and measurement is by an electrochemical biosensor technology using glucose oxidase (A. Niger).

- 7. Performance Characteristics:
Results of the performance tests including system accuracy, user study precision, interference, hematocrit, altitude, meter reliability, storage stability and in-use stability demonstrate that the BIOLAND G-423 BLOOD GLUCOSE MONITORING SYSTEM, MODEL G-423, met the performance requirements for its intended use. Software validation, EMC and safety testing are also performed and the results met the predetermined acceptance criteria. The data demonstrates that the BIOLAND BLOOD GLUCOSE MONITORING SYSTEM MODEL G-423 is substantially equivalent to the predicate device.

- 8. Conclusion:
Based on the information provided in this submission, the BIOLAND G-423 BLOOD GLUCOSE MONITORING SYSTEM MODEL G-423 is substantially equivalent to the predicate device.

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Image /page/3/Picture/12 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

10903 New Hampshire Avenue Silver Spring, MD 20993

> 3 2012 AUG

Taidoc Technology Corporation c/o Linda Ko 3F, 5F, No. 127, Wugong 2nd Rd Wugu Township, Wugu Dist. New Taipei City China (Taiwan) 24888

k113077 Re:

Trade Name: Bioland G-423 Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: July 17, 2012 Received: August 1, 2012

Dear Ms Ko:

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 either class II (Special Controls) or class III (PMA), 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. or mo recor any coubla 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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/Resourcesfor You/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 (if known):

Device Name: Bioland G-423 Blood Glucose Monitoring System, Model G-423

Indications for Use:

The Bioland G-423 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. This system is intended to be used by a single person and should not be shared.

The Bioland G-423 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 Bioland G-423 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

The Bioland G-423 Test Strips are for use with the Bioland G-423 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

AND/OR

Prescription Use ________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (21 CFR 801 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)

Division Sign-Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) ≤113077

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