BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234

K091898 · Taidoc Technology Corporation · NBW · Sep 18, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091898
• Device Name: BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FORA G90 / U-Right TD-4234 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, nor is it intended for use on newborns. The alternative site testing in this system can be used only during steady-state blood glucose conditions.

Device Story

FORA G90 / U-Right TD-4234 is a blood glucose monitoring system for quantitative measurement of glucose in fresh capillary whole blood. Used by healthcare professionals and patients with diabetes at home to monitor diabetes control programs. Input: capillary blood sample via test strip. Operation: electrochemical biosensor technology; device measures electrical current proportional to glucose concentration in sample. Output: digital glucose concentration displayed on device screen. Supports alternative site testing (palm, forearm, upper-arm, calf, thigh) during steady-state conditions. Provides immediate feedback to patients and clinicians for diabetes management.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design control activities, risk analysis, and verification/validation of engineering modifications.

Technological Characteristics

Electrochemical biosensor; quantitative measurement of glucose in capillary whole blood. Supports alternative site testing. Device is a portable blood glucose meter. Software-based processing of electrical signals from test strips.

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. Contraindicated for neonates and for diabetes diagnosis/screening. Alternative site testing restricted to steady-state glucose conditions.

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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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

SEP 18 2009 .

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

TaiDoc Technology Corporation c/o Ms. Erica Li 6F, No. 127, Wugong 2nd Rd., Wugu Township Taipei County, 24888 Taiwan, R.O.C.

Re: k091898

Trade name: FORA G90 Blood Glucose Monitoring System, U-Right TD-4234 Blood Glucose Monitoring System

Regulation Number: 21 CFR 862.1345

Regulation Name: Glucose Test System

Regulatory Class: Class II

Product Code: NBW, CGA

Dated: August 14, 2009

Received: August 18, 2009

Dear Ms. Li:

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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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 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 device adverse events (Medical Device Reporting (MDR)). please contact the Division of Surveillance Systems at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Courthey 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

Enclosure

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## Attachment 2-1

## Indications for Use

510(k) Number:

Ka1898

Device Name:

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

Indications for Use:

The FORA G90 / U-Right TD-4234 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, nor is it intended for use on newborns.

The alternative site testing in this system can be used only during steady-state blood glucose conditions.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use ਮ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Division Sign-Off

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Office of In Vitro Diagnos Descr Evaluation and S

500K K-091898