CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS

K051936 · Taidoc Technology Corporation · NBW · Aug 8, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051936
• Device Name: CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

These Clever Chek TD-3215™ / Dr. T TD-3216™ Blood Glucose and Blood Pressure Measurement Systems are intended for in vitro diagnostic use. These systems are intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates. These systems are also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".

Device Story

Device modification involving change to mechanical appearance of top cover. Subject device is a modification of previously cleared device (K042795). Fundamental scientific technology remains unchanged. Modification assessed via design control activities, risk analysis, and verification/validation testing to ensure safety and performance.

Clinical Evidence

No clinical data; bench testing only via design control verification and validation activities.

Technological Characteristics

Mechanical modification to device top cover; fundamental scientific technology unchanged from predicate (K042795).

Indications for Use

Indicated for quantitative glucose measurement in capillary whole blood (fingertip) for diabetes management in patients with diabetes mellitus; not for neonates or diabetes diagnosis/screening. Also indicated for non-invasive systolic/diastolic blood pressure and pulse rate measurement in adults >16 years old with wrist circumference 5.25"-7.75".

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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Public Health Service

Image /page/0/Picture/3 description: The image shows the date August 8, 2005. The month is represented by the abbreviation AUG. The day is represented by the number 8, and the year is represented by the number 2005. The date is written in a simple, sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Sophia, Shu-Mei Wu, Ph.D. TaiDoc Technology Corporation 4F, No. 88, Sec. 1, Kwang-Fu Rd., San-Chung Taipei County 241 Taiwan

Re: k051936

Trade/Device Name: Clever Chek TD-3215™ Dr. T TD-3216TM Blood Glucose and Blood Pressure Measurement System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 14, 2005 Received: July 18, 2005

Dear Dr. Wu:

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) I ms letter will anow you to begin managing of substantial equivalence of your device to a legally premarket notification: "The Pull 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, IT you desire specific information acountising of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the VITO Dagnostic Do Moo Danding by reference to premarket notification" (21 CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the I ou may outlict general monitations on Jour 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,

Carol C. Benem

Carol C. Benson, M.A. 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

## Indications for Use

510(k) Number:

Device Name: Clever Chek TD-3215™ I Dr. T TD-3216™ Blood Glucose and Blood Pressure Measurement System

Indications for Use:

These Clever Chek TD-3215"M / Dr. T TD-3216"M Blood Glucose and Blood Pressure Measurement Systems are intended for in vitro diagnostic use.

These systems are intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates.

These systems are also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".

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

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

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

oncurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD)

Office of In Vitro Diagnostic Deidee FEvaluation and Safet A2 - 1

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5510(k) K051936