FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM

K100405 · Taidoc Technology Corporation · CGA · Jul 9, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100405
• Device Name: FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jul 9, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FORA G90 Perform Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, forearm, upper arm, calf, or thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control programs. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

System comprises meter, test strips, and control solutions; utilizes electrochemical biosensor technology with glucose oxidase to measure glucose in fresh capillary whole blood. Designed for home use by patients with diabetes or by healthcare professionals. Device provides quantitative glucose readings to assist in monitoring diabetes control programs. Modifications from predicate include implementation of 'no-coding' functionality and preset mg/dL measurement units. Users apply blood sample to test strip; meter processes signal to display glucose concentration. Results aid in clinical decision-making regarding diabetes management. Not for diagnostic or screening purposes; not for neonatal use.

Clinical Evidence

Bench testing only. System accuracy performance was compared to the predicate device (K091898). Software verification and validation testing confirmed performance, safety, and effectiveness are equivalent to the predicate.

Technological Characteristics

Electrochemical blood glucose monitoring system. Software-controlled measurement. Modification: firmware update to disable code display and lock units to mg/dL. Fundamental sensing technology unchanged from predicate.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (finger, palm, forearm, upper arm, calf, thigh) for healthcare professionals and patients with diabetes mellitus to monitor diabetes control. Not for diabetes diagnosis/screening or neonatal use.

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

• FORA G90/U-RIGHT TD-4234 Blood Glucose Monitoring System (K091898)

Submission Summary (Full Text)

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## Attachment 4. 510(k) Summary

# JUL--9 2010

1 j {

#### 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:

- 1. Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
Correspondence: Nicky Pan Regulatory Affairs Specialist Tel: [phone] #1196 Fax: [phone] Email: [e-mail]

Date of submission: 02/12/2010

- 2. Device name:
Proprietary name: FORA G90 Perform Blood Glucose Monitoring System

Regulatory information:

- Regulation section: 21 CFR 862.1345 Glucose Test System A.
- B. Classification: Class II

C. Product Code: CGA, Glucose Oxidase, Glucose NBW, System, Test, Blood Glucose, Over The Counter D. Panel: Chemistry (75)

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#### 3. Intended Use:

The FORA G90 Perform Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The alternative site testing in the FORA G90 Perform Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

### 4. Device Description:

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA G90 Perform test strips and control solutions with the FORA G90 Perform Blood Glucose Monitoring System.

#### Substantial Equivalence Information:

A. Predicate device name:

FORA G90/U-RIGHT TD-4234 Blood Glucose Monitoring System

B. Predicate K number: K091898

C. Comparison with predicate:

The modified FORA G90 blood glucose monitoring system has the following similarities to the predicate device:

- 비 same operating principle,
- . same fundamental scientific technology,

● incorporate the same basic circuit design.

- I incorporate the same materials,
- same shelf life

packaged using the same materials, and

Manufactured by the same process.

#### A4-2 of 3

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The modifications encompass:

- 배 Software modification to no-coding
- I Addition of "no-coding" phrase on the labeling
- Software modification to use mg/dL as the preset measurement. ●

### 5. Test Principle:

The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase.

- 6. Performance Characteristics:
FORA G90 Perform blood glucose monitoring system has the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the FORA G90 Perform blood glucose monitoring system and the currently marketed FORA G90/TD-4234 Blood Glucose Monitoring System (cleared under K091898) arc substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA G90 Perform blood glucose monitoring system is equivalent to the predicate device.

#### 7. Conclusion:

Based on the information provided in this submission, the FORA G90 Perform blood glucose monitoring system is substantially equivalent to the predicate FORA G90/TD-4234 Blood Glucose Monitoring System.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is aligned to the left. There is a logo to the left of the text, but it is not clear what the logo is.

Public Health Service

TaiDoc Technology Corporation c/o Nicky Pan Regulatory Affairs Specialist 3F, 5F, No. 127, Wugong 2nd Rd Wugu Township Taipei County, China (Taiwan) 248

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

# JUL 0 9 2010

Re: k100405

> Trade name: FORA G90 Perform Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: June 22, 2010 Received: June 30, 2010

Dear Nicky Pan:

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, fisting 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. 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

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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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

CA

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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# Indications for Use Form

510(k) Number (if known): K100405

Device Name: FORA G90 Perform Blood Glucose Monitoring System

Indications for Use:

The FORA G90 Perform Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The alternative site testing in the FORA G90 Perform Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Prescription Use X (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 OF NEEDED)

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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

510(k) K/DO 405

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