FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254

K082482 · Taidoc Technology Corporation · CGA · Jan 30, 2009 · Clinical Chemistry

Device Facts

• Record ID: K082482
• Device Name: FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254
• Applicant: Taidoc Technology Corporation
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 30, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FORA TD-4251, URIGHT TD-4252, URIGHT TD-4254 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

Blood glucose monitoring system; measures glucose in capillary whole blood samples; utilizes electrochemical biosensor technology; provides quantitative glucose concentration output; used by patients at home or healthcare professionals in clinical settings; aids in diabetes management; modification of previously cleared TD-4230 Clever Check system; involves external casing redesign; fundamental scientific technology remains unchanged.

Clinical Evidence

No clinical data provided in the document. Substantial equivalence is based on bench testing and performance characteristics typical for glucose monitoring systems.

Technological Characteristics

Electrochemical blood glucose monitoring system; external casing redesigned from predicate; fundamental sensing technology unchanged; standalone device; intended for point-of-care or home use.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (finger, palm, upper-arm, calf, thigh) for healthcare professionals and patients with diabetes mellitus to monitor glycemic control. Contraindicated for neonates and non-steady-state glucose conditions for alternative site testing.

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)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

TaiDoc Technology Corporation c/o Ms. Sophie Lin, Specialist Regulatory Affairs 6F, No. 127, Wugong 2nd Road Wugu Township, Taipei, Taiwan 248

Re: k082482

Trade/Device Name: FORA TD-4251, U-Right TD-4252, U-Right TD-4254 Blood Glucose Monitoring Systems

JAN 3 0 2009

Regulation Number: 21 CFR§ 862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Code: NBW, CGA Dated: December 19, 2008 Received: January 12, 2009

Dear Ms. Lin:

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).

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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.htm].

Sincerely vours.

Coy C. Ht

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

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## Attachment 2

## Indications for Use

K082482 510(k) Number:

Device Name: FORA TD-4251 /U-RIGHT TD-4252/ U-RIGHT TD-4254 Blood Glucose Monitoring System

Indications for Use:

The FORA TD-4251 /U-RIGHT TD-4252/ U-RIGHT TD-4254 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 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-4251 /U-RIGHT TD-4252/ U-RIGHT TD-4254 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Prescription Use (21 CFR Part 801 Subpart D)

Over the Counter Use _ And/Or (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 (OVD)

Carol C. Benam

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

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