MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS

K093635 · Taidoc Technology Corporation · NBW · Feb 18, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093635
• Device Name: MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 18, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FORA V30 Blood Glucose Monitoring System/TD-4242 Blood Glucose Monitoring System are 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 V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions. This meter has some speaking functions but is not intended for use by the visually impaired.

Device Story

System measures glucose in fresh capillary whole blood via electrochemical biosensor (glucose oxidase). Components include meter, test strips, control solution, lancing device, and lancets. Used by healthcare professionals or patients at home to monitor diabetes control programs. Device features speaking functions for audio output, though not intended for visually impaired users. Output provides quantitative glucose concentration to assist in diabetes management. Modifications from predicate include software updates, addition of voice chip/speaker, and physical appearance changes.

Clinical Evidence

No clinical data provided. Substantial equivalence established via design control activities, risk analysis, and verification/validation of device modifications.

Technological Characteristics

Glucose meter; electrochemical sensing principle; powered by two AAA alkaline batteries; includes voice chip and speaker for audio output; software-controlled display and unit settings (fixed mg/dL).

Indications for Use

Indicated for use by patients for the quantitative measurement of glucose in capillary whole blood as an aid in monitoring the effectiveness of diabetes control programs.

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 G30/TD-4241 Blood Glucose Monitoring System (K090187)

Submission Summary (Full Text)

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### Attachment 6. 510(k) Summary

# FEB 1 8 2010

### 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: K093635

- 1. Submitter's Identification: TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
Correspondence: Debra Liang Regulatory Affairs Specialist Tel: [phone] #1198 Fax: [phone] Email: [e-mail]

Date of submission: 11.20.2009

- 2. Device name:
Proprietary name: FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System

Regulatory information:

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

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#### 3. İntended Use:

The FORA V30 Blood Glucose Monitoring System/TD-4242 Blood Glucose Monitoring System are 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 V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

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

- 4. Device Description:
The kit of FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring Systems consist of Glucose Meter, Test Strips, Control solution, A commercially available lancing device and sterile Lancets, User Manual, and Storage Pack.

- 5. Substantial Equivalence Information:
Predicate device name: A.

FORA G30/TD-4241 Blood Glucose Monitoring System

- B. Predicate K number: K090187
C. Comparison with predicate:

The modified FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring Systems have the following similarities to the predicate device:

- same operating principle,
- same fundamental scientific technology, ■
- incorporate the same basic circuit design, .
- . incorporate the same materials,

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- same shelf life
- packaged using the same materials, and
- Manufactured by the same process. I

The modifications encompass:

- A modification in the software of the glucose meter 배
- 일 Speaking function
- Modification in the physical appearance ■
- Addition of components: voice chip and speaker
- 1 Labeling change due to the software modification
- 6. Test Principle:

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

- 7. Performance Characteristics:
FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System have the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System and the currently marketed FORA G30/TD-4241 Blood Glucose Monitoring System are substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring Systems are equivalent to the predicate device.

- 8. Conclusion:
Based on the information provided in this submission, the FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System are substantially equivalent to the predicate FORA G30/TD-4241 Blood Glucose Monitoring System.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a series of three curved lines that resemble a stylized staff with intertwined snakes, a symbol often associated with medicine and healthcare.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

FEB 1 8 2010

TaiDoc Technology Corporation c/o Ms. Debra Liang Specialist, Regulatory Affairs 6F, No.127, Wugong 2nd Rd. Wugu Township, Taipei County China (Taiwan) 24888

Re: k093635

> Trade/Device Name: FORA V30 Blood Glucose Monitoring System/TD-4242 Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: December 23, 2009 Received: January 20, 2010

Dear Ms. Debra Liang:

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 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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Page 2

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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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## Attachment 12. Indications for Use

#### Indications for Use

510(k) Number: K093635

Device Name: FORA V30 Blood Glucose Monitoring System/TD-4242 Blood Glucose Monitoring System

Indications for Use:

The FORA V30 Blood Glucose Monitoring System/TD-4242 Blood Glucose Monitoring System are 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 V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

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

Prescription Use _ (21 CFR Part 801 Subpart D)

And/Or Over the Counter Use __ X (21 CFR Part 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 Evaluation and Safety (OIVD)

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

K 093635 510(k) =

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