CLEVER CHEK TD-3213

K042795 · Taidoc Technology Corporation · NBW · Mar 7, 2005 · Clinical Chemistry

Device Facts

• Record ID: K042795
• Device Name: CLEVER CHEK TD-3213
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. 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 not intended for use on neonates. The system is 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

System combines blood glucose meter and wrist-cuff blood pressure monitor. Glucose testing: electrochemical method using dry reagent biosensor test strips; current proportional to glucose concentration in fresh capillary whole blood. Blood pressure testing: oscillometric method; pressure sensor detects cuff pressure alterations; converts to electrical signals to calculate systolic/diastolic pressure and pulse rate. Used at home by patients or in clinical settings by professionals. Output displayed on meter screen for patient monitoring of diabetes and cardiovascular health; aids in diabetes control program management.

Clinical Evidence

Performance evaluated in laboratory and clinical settings by healthcare professionals and lay users. Studies demonstrated the system is suitable for its intended use. No specific sensitivity/specificity metrics provided in summary.

Technological Characteristics

Integrated meter with wrist cuff and dry reagent biosensor test strips. Glucose sensing: electrochemical. Blood pressure sensing: oscillometric (pressure sensor). Wrist cuff circumference: 5.25"-7.75".

Indications for Use

Indicated for quantitative glucose measurement in capillary whole blood (fingertip) for diabetes monitoring by healthcare professionals or patients at home; not for neonates or diabetes diagnosis. Also indicated for non-invasive systolic/diastolic blood pressure and pulse rate measurement in adults >16 years 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.

Predicate Devices

• GLUCOMETER ELITE Diabetes Care System (K020208)
• APM Blood Pressure Monitoring System, BP108A (K040159)

Submission Summary (Full Text)

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Koyrys

MAR 7 - 2005

# 510 (k) Summary

Page 1-of-3

| 1. Submitter Information | | TaiDoc Technology Corporation |
|---------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | | Shu-Mei Wu |
| Contact person | | 4F, No. 88, Sec. 1, Kwang-Fu Rd.,<br>San-Chung, Taipei County, Taiwan |
| Address | | |
| Phone | | [phone] |
| FAX | | [phone] |
| E-mail | | [e-mail] |
| Date Prepared | | October 3 , 2004 |
| 2. Name of Device | | |
| Trade Names | | CLEVER CHEK TD-3213TM<br>Blood Glucose and Blood Pressure<br>Measurement System |
| Common Names/Descriptions | | Blood Glucose and Blood Pressure Measurement<br>System<br>Blood Glucose Test Strips |
| Classification Names | | Class II devices<br>21 CFR Section 862.1345, Glucose Test System;<br>21 CFR Section 870.1130, Non-invasive Blood<br>Pressure Measurement System |
| 3. Predicate Device | | |
| Trade/Proprietary Name: | | GLUCOMETER ELITE Diabetes Care System<br>APM Blood Pressure Monitoring System,<br>BP108A |
| Common/Usual Name: | | Blood Glucose Meter; Non-invasive Blood<br>Pressure Measurement System<br>Blood Glucose Test Strips |
| Manufacturer | | Bayer Diagnostics<br>Asia Pacific Microsystems, Inc. |
| 510 (k) Number | | K020208; K040159 |

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## 4. Device Description

The CLEVER CHEK TD-3213TM blood glucose and blood pressure measurement system consists of a meter with wrist cuff and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions. Also, the system adopts the "oscillometric method" to as the measuring principle and provides the measurement of the systolic and diastolic blood pressure and heart rate of an individual by using a non-invasive technique in which as inflatable cuff is wrapped around the wrist. The pressure sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to determine the systolic and diastolic blood pressure and calculating pulse rate.

#### 5. Intended Uses

The CLEVER CHEK TD-3213™ system is indicated for the quantitative measurement of glucose in fresh whole blood (capillary blood) for self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities. Testing is done outside the body (in vitro diagnostic use). The system also intended to use non-invasive measure the systolic and diastolic blood pressure and pulse rate or an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".

### 6. Comparison to Predicate Device

The CLEVER CHEK TD-3213TM system has equivalent technological characteristics as the GLUCOMETER ELITE Diabetes Care System (K020208) and APM Blood Pressure Monitoring System, BP108A (K040159). The CLEVER CHEK TD-3213TM system also has the same intended use as the GLUCOMETER ELITE Diabetes Care System and APM Blood Pressure Monitoring System, BP108A.

#### 7. Performance Studies

The performance of the CLEVER CHEK TD-3213™ system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the CLEVER CHEK TD-3213TM system is suitable for its intended use

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Page 3-of-3

8. Conclusions

e: "Concerablems"
The CLEVER CHEK TD-3213™ system demonstrates satisfactory performance and is suitable for their intended uses.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a stacked formation.

MAR 7 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Shu-Mei Wu, Ph.D. Project Manager Taidoc Technology Corporation 4F, 88, Sec.1, Kwang Fu Road San Chung, Taipei China (Taiwan) 241

k042795 Re:

Trade/Device Name: Clever Chek TD-3213 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, CGA, JJX, DXN Dated: January 12, 2005 Received: January 14, 2005

Dear Shu-Mei 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 cither 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,

Jean M. Cooper MS, DUM

Jean M. Cooper, MS, 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: K042795

# Device Name: Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System

Indications For Use:

The Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System is intended for in vitro diagnostic use.

The system is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. 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 not intended for use on neonates.

The system is 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

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

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

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

Jices

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