FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM

K112275 · Taidoc Technology Corporation · NBW · Dec 15, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112275
• Device Name: FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 15, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FORA Premium V10 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. 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 glucose 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 single patient; not for visually impaired despite speaking functions. Input: capillary blood sample on test strip; Output: quantitative blood glucose concentration displayed on meter. Modifications from predicate include physical appearance, minor software updates, and transition from RS-232 to USB data transmission. Healthcare provider uses output to assess diabetes control program effectiveness; patient uses results for self-management. Benefits include convenient, accurate, and rapid glucose monitoring.

Clinical Evidence

Bench testing only. System accuracy performance compared against predicate device (FORA V30) demonstrated substantial equivalence. Software verification and validation testing confirmed performance, safety, and effectiveness equivalent to predicate.

Technological Characteristics

Handheld blood glucose meter. Electrochemical sensing principle. USB connectivity. Powered by internal battery. Materials validated for 5,000 cleaning/disinfection cycles. Software-based data processing and storage. Single-patient use design.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from the finger for home use by individuals with diabetes to monitor glycemic control. Not for neonatal use or diabetes screening/diagnosis.

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 V30 blood glucose monitoring system (K093635)

Submission Summary (Full Text)

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DEC 1 5 2011

## 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: K112275

- 1. Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 248, Taiwan
Correspondent: Teling Hsu Regulatory Affairs Specialist Tel: [phone] #1176 Fax: [phone] Email: teling.hsu(@taidoc.com.tw

Prepared date: Aug 03, 2011

- 2. Device name:
Proprietary name: FORA Premium V10 Blood Glucose Monitoring System

Regulatory information:

- A. Regulation section: 21 CFR 862.1345 Glucose Test System
- Classification: Class II B.
- Product Code: CGA, Glucose Oxidase, Glucose C.
- NBW, System, Test, Blood Glucose, Over The Counter
- D. Panel: Clinical Chemistry (75)

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- 3. Intended Use:
The FORA Premium V10 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: palm, forearm, upper-arm, calf and thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. This system is intended to be used by a single person and should not be shared. 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 Premium V10 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The FORA Premium V10 Test Strips are for use with the FORA Premium V10 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper-arm, calf and thigh.

This meter has some speaking functions but is not intended for use by the visually impaired.

- 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 test strips and FORA control solutions (cleared under k093724) with the FORA Premium V10 Blood Glucose Monitoring System.

- 5. Substantial Equivalence Information:
- A. Predicate device name: FORA V30 blood glucose monitoring system
- B. Predicate K number: K093635
- C. Comparison with predicate:

The modified FORA Premium V10 Blood Glucose Monitoring System has the following similarities to the predicate device:

- 1 same operating principle,
- I same fundamental scientific technology,
- 트 incorporate the same basic circuit design,
- incorporate the same materials,
- . same shelf life

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- packaged using the same materials, and
- manufactured by the same process.

The modifications encompass:

- Modification in the physical appearance
- . Minor software modifications of the glucose meter
- Change of the data transmission method from RS-232 to USB
- 그 Labeling change due to the above modifications
- 6. Test Principle:

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

- 7. Performance Characteristics:
FORA Premium V10 Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the FORA Premium V10 Blood Glucose Monitoring System and the FORA V30 Blood Glucose Monitoring System are substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA Premium V10 Blood Glucose Monitoring System are equivalent to the predicate device.

- 8. Conclusion:
Based on the information provided in this submission, the FORA Premium V10 Blood Glucose Monitoring System is substantially equivalent to the predicate FORA V30 blood glucose monitoring system.

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Image /page/3/Picture/13 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

10903 New Hampshire Avenue Silver Spring, MD 20993

TAIDOC TECHNOLOGY CORPORATION C/O TELING HSU 3F-5F NO. 127 WUGONG 2ª0 RD. WUGU DISTRICT NEW TAIPEI CITY CHINA (TAIWAN) 24888

DEC 1 5 2011

Re: k112275

> Trade Name: FORA Premium V10 Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW. CGA Dated: November 16, 2011 Received: November 22, 2011

Dear Ms. Hsu:

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. 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); 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,

Signature

Couriney 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

51.0(k) Number (if known): k112275

Device Name: FORA Premium V10 Blood Glucose Monitoring System, model TD-4124 Indications for Use:

The FORA Premium V10 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: palm, forearm, upper-arm, calf and thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. This system is intended to be used by a single person and should not be shared. 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 Premium V10 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The FORA Premium V10 Test Strips are for use with the FORA Premium V10 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper-arm, calf and thigh.

This meter has some speaking functions but is not intended for use by the visually impaired.

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 Device (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K 1122 )

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