FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245

K083664 · Taidoc Technology Corporation · CGA · Jan 9, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083664
• Device Name: FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245
• Applicant: Taidoc Technology Corporation
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 9, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FORA TD-4245 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 TD-4245 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions. The FORA TD-4245 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Device Story

Glucose meter; modified version of previously cleared device (K073119). Modifications limited to name, physical appearance, size, and weight. Device measures glucose levels in blood samples. Used by patients or clinicians for monitoring. Fundamental scientific technology remains unchanged from predicate. Design control activities, including risk analysis and verification/validation, performed to ensure safety and performance post-modification.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Glucose meter; electrochemical sensing principle. Modifications involve physical form factor (size, weight, appearance). Fundamental scientific technology unchanged from predicate. Sterilization and material specifications not detailed.

Indications for Use

Indicated for use as a glucose meter for the quantitative measurement of glucose in blood.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a cross. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all caps and appears to be in a simple, sans-serif font.

## FEB 5 - 2009

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Taidoc Technology Corporation c/o Yuhua Chen, Assistant Manager, Regulatory Affairs 6F, No.127, Wugong 2nd Rd, Wugu Taipei County China (Taiwan) 248

Re: k083664

Trade/Device Name: FORA TD-4245 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: November 12, 2008 Received: December 10, 2008

Dear Yuhua Chen:

This letter corrects our substantially equivalent letter of January 9, 2009.

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{1}------------------------------------------------

Page - 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html.

Sincerely yours.

Corg C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a black and white drawing of what appears to be a cell undergoing mitosis. The cell is in the metaphase stage, where the chromosomes are aligned in the middle of the cell. The chromosomes are visible as dark, condensed structures. The cell membrane is also visible as a thin, dark line around the cell.

## Attachment A

## Indications for Use

510(k) Number:

Device Name: FORA TD-4245 Blood Glucose Monitoring System

Indications for Use:

The FORA TD-4245 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 TD-4245 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The FORA TD-4245 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

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)

Cawl C. Benson

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

510(k) K083664

Page 1 of ____________________________________________________________________________________________________________________________________________________________________