ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455

K082618 · Taidoc Technology Corporation · NBW · Oct 7, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082618
• Device Name: ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 7, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The UltraTRAK PRO 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 UltraTRAK PRO Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Device Story

UltraTRAK PRO Blood Glucose Monitoring System measures glucose in fresh capillary whole blood; inputs include blood samples from finger or alternative sites (palm, upper-arm, calf, thigh). Device uses electrochemical biosensor technology to quantify glucose levels; output is numerical blood glucose concentration displayed to user. Intended for home use by patients with diabetes or clinical use by healthcare professionals. Provides real-time monitoring to assist in diabetes management; aids in assessing effectiveness of diabetes control programs. Not for diagnostic or screening purposes; alternative site testing requires steady-state conditions.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on bench testing and performance characteristics.

Technological Characteristics

Electrochemical glucose test system; utilizes capillary whole blood samples. Designed for finger and alternative site testing (palm, upper-arm, calf, thigh). System includes meter and test strips. Connectivity and specific software architecture details not provided. Sterilization and material specifications not detailed in provided text.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from finger, palm, upper-arm, calf, and thigh. For use by healthcare professionals and patients with diabetes mellitus to monitor diabetes control. Contraindicated for neonates and for diagnosis or screening of diabetes. 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## OCT 0 7 2008

TaiDoc Technology Corp. c/o Yuhua Chen Specialist Regulatory Affairs 6F, No. 127, Wugong 2nd Road Wugu Township, Taipei County China (Taiwan) 248

Re: k082618

> Trade Name: UltraTRAK PRO Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW, CGA Dated: September 5, 2008 Received: September 9, 2008

Dear Yuhua Chen:

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. Iisting 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 tollit the [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.v.M.

Yéan M. Cooper, M.S., D.V.M. 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

## Indications for Use

510(k) Number: K082418

Device Name: UltraTRAK PRO Blood Glucose Monitoring System

Indications for Use:

The UltraTRAK PRO 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 UltraTRAK PRO 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 X 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. Benson

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

510(k) K082618

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