CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM

K063212 · Taidoc Technology Corporation · NBW · Nov 22, 2006 · Clinical Chemistry

Device Facts

• Record ID: K063212
• Device Name: CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 22, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TD-4231 and TD-4223 blood glucose monitoring systems are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, forearm, or upper arm. The systems are intended for use by a single person and should not be shared. The systems are intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The systems are not intended for the diagnosis of or screening for diabetes mellitus, nor for use on neonates.

Device Story

System measures glucose in fresh capillary whole blood via finger or alternative sites (palm, forearm, upper-arm, calf, thigh). Used by healthcare professionals and patients with diabetes at home to monitor glycemic control. Not for diagnosis or screening. Operates via electrochemical biosensor technology; blood sample applied to test strip; meter calculates glucose concentration; results displayed on screen. Assists in diabetes management; alternative site testing limited to steady-state conditions.

Clinical Evidence

No clinical data provided in the summary document.

Technological Characteristics

In vitro diagnostic blood glucose monitoring system. Features LCD display with range indicators, strip ejector mechanism, manual code entry interface, and optional audio output. Operates via electrochemical biosensor technology. Software-controlled features include range classification and alarm scheduling.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from finger, palm, forearm, or upper arm for single-patient self-testing by individuals with diabetes to monitor glycemic control. Not for neonatal use or diabetes screening/diagnosis.

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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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Pi-Shiou Li Management Representative TaiDoc Technology Corporation 4F, No. 88, Sec. 1, Kwang-Fu Rd., San-Chung Taipei County, Taiwan 241

NOV 2 2 2006

Re: k063212

> Trade/Device Name: Clever Chek TD-4231 Blood Glucose Monitoring System Clever Chek TD-4223 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: October 18, 2006 Received: October 23, 2006

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); 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/industry/support/index.html.

Sincerely yours,

Alberto Gutz

Alberto Gutierrez, 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 2

## Indications for Use

KO63 212 510(k) Number:

Clever Chek TD-4231 Blood Glucose Monitoring System Device Name: Clever Chek TD-4223 Blood Glucose Monitoring System

Indications for Use:

The Clever Chek TD-4231/ Clever Chek TD-4223 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 Clever Chek TD-4231/ Clever Chek TD-4223 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Prescription Use AND/OR Over-The-Counter Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

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

Carol Benson

Thision 3 . 1 . 19

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Office of In Vitro Diagnostic Device Evaluation and Statual

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