CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237

K081609 · Taidoc Technology Corporation · CGA · Jul 2, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081609
• Device Name: CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237
• Applicant: Taidoc Technology Corporation
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jul 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Clever Chek TD-4237 / AudioChek 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 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-4237 / AudioChek Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions. The Clever Chek TD-4237 / AudioChek Blood Glucose Monitoring System contain a speaking functionality which provides step by step instructions to aid visually impaired persons.

Device Story

Clever Chek TD-4237 / AudioChek Blood Glucose Monitoring System; quantitative measurement of glucose in fresh capillary whole blood. Input: capillary blood sample from finger or alternative sites (palm, forearm, calf, thigh). Operation: electrochemical biosensor technology; converts glucose concentration to electrical signal; provides digital readout. Includes integrated speaking functionality for step-by-step audio instructions to assist visually impaired users. Used by healthcare professionals or patients at home for diabetes management. Output: blood glucose concentration displayed on screen and/or announced via audio. Assists in monitoring diabetes control program effectiveness.

Clinical Evidence

No clinical data provided; substantial equivalence based on design control activities, risk analysis, and verification/validation of physical/functional modifications.

Technological Characteristics

Electrochemical glucose monitoring system; utilizes capillary whole blood samples. Features integrated audio output for accessibility. Designed for both professional and home use. System includes meter and test strips for quantitative glucose measurement.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from finger, palm, forearm, calf, and thigh. Intended for healthcare professionals and patients with diabetes mellitus for monitoring diabetes control programs. Contraindicated for neonates and for diagnosis or screening of diabetes mellitus. 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

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

JUL - 3 2008

Re: k081609

> Trade Name: Clever Chek TD-4237 Blood Glucose Monitoring System AudioChek Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW, CGA Dated: June 06, 2008 Received: June 09, 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, 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yean 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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## Indications for Use

510(k) Number: K081609

Device Name: Clever Chek TD-4237 Blood Glucose Monitoring System AudioChek Blood Glucose Monitoring System

Indications for Use:

The Clever Chek TD-4237 / AudioChek 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 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-4237 / AudioChek Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The Clever Chek TD-4237 / AudioChek Blood Glucose Monitoring System contain 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 (OVD)

Carol C. Benson

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

510(k) K081609

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