CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250

K061073 · Taidoc Technology Corporation · DXN · Jun 2, 2006 · Cardiovascular

Device Facts

• Record ID: K061073
• Device Name: CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250
• Applicant: Taidoc Technology Corporation
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Clever Chek TD-3250 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 capillary whole blood from the finger. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a 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 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 arm. The cuff circumference is limited to 9.4 inches to~ 13.8 inches.

Device Story

System combines blood glucose meter and non-invasive blood pressure monitor. Glucose testing: electrochemical method using dry reagent biosensor test strips; current proportional to glucose concentration in fresh whole blood. Blood pressure testing: oscillometric method; inflatable arm cuff; pressure sensor converts cuff pressure alterations to electrical signals to determine systolic/diastolic pressure and pulse rate. Used by patients at home or healthcare professionals in clinical settings. Output provided to user for monitoring diabetes control and cardiovascular metrics. Benefits include integrated management of glucose and blood pressure in single device.

Clinical Evidence

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

Technological Characteristics

Integrated system comprising electrochemical glucose meter and oscillometric blood pressure monitor. Uses dry reagent biosensors for glucose. Employs pressure sensor for cuff-based blood pressure measurement. Arm cuff circumference 9.4-13.8 inches. Connectivity and software details not specified.

Indications for Use

Indicated for quantitative capillary whole blood glucose monitoring in patients with diabetes mellitus (home or clinical use) and non-invasive systolic/diastolic blood pressure and pulse rate measurement in adults over age 16 (home use). Not for neonates or diabetes screening/diagnosis. Cuff size 9.4-13.8 inches.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• Achtung TD-4207 Blood Glucose Test System (K042005)
• BpTRU Automated Non-Invasive Blood Pressure Monitoring, BMP-100 (K012636)

Submission Summary (Full Text)

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K061073

Page 1-of-3

JUN - 2 2006

# 510 (k) Summary

1. Submitter Information Manufacturer Contact person

Address

Phone FAX E-mail Date Prepared

:

2. Name of Device Trade Names

Common Names/Descriptions

Classification Names

3. Predicate Device Trade/Proprietary Name:

Common/Usual Name:

Manufacturer

510 (k) Number

TaiDoc Technology Corporation Shu-Mei Wu 4F, No. 88, Sec. 1, Kwang-Fu Rd., San-Chung, Taipei County, Taiwan [phone] [phone] [e-mail] April 14, 2006

CLEVER CHEK TD-3250TM

Blood Glucose and Blood Pressure Measurement System Blood Glucose and Blood Pressure Measurement System Blood Glucose Test Strips Class II devices 21 CFR Section 862.1345, Glucose Test System; 21 CFR Section 870.1130, Non-invasive Blood Pressure Measurement System

Achtung TD-4207 Blood Glucose Test System BpTRU Automated Non-Invasive Blood Pressure Monitoring, BMP-100 Blood Glucose Meter; Non-invasive Blood Pressure Measurement System Blood Glucose Test Strips TaiDoc Technology Corporation. VSM MedTech Ltd. K042005; K012636

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## 4. Device Description

The CLEVER CHEK TD-3250™ blood glucose and blood pressure measurement system consists of a meter with arm 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 . The pressure sensor converts tiny alterations in arm 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-3250™ 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 . The arm cuff circumference is limited to 9.4"~13.8".

#### 6. Comparison to Predicate Device

The CLEVER CHEK TD-3250™ system has equivalent technological characteristics as the Achtung TD-4207 Blood Glucose Test System (K042005) and BpTRU Automated Non-invasive Blood Pressure Monitor, BP-100 (K012636). The CLEVER CHEK TD-3250™ system also has the same intended use as the Achtung TD-4207 Blood Glucose Test System and BpTRU Automated Non-invasive Blood Pressure Monitor, BP-100.

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### 7. Performance Studies

The performance of the CLEVER CHEK TD-3250™ system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the CLEVER CHEK TD-3250™ system is suitable for its intended use

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8. Conclusions

The CLEVER CHEK TD-3250™ system demonstrates satisfactory performance and is suitable for their intended uses.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 5 2006

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

k061073 Re: Trade/Device Name: Clever Chek TD-3250 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: April 14, 2006 Received: April 17, 2006

Dear Dr. Shu-Mei Wu:

This letter corrects our substantially equivalent letter of June 2, 2006.

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.

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Page 2 - Dr. Shu-Mei Wu

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).

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,

Carol Benson for

Alberto Gutierrez Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics Device Evaluation and Safety Center for Devices and Radiological Health

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## Indications for Use

#### 510(k) Number (if known): k061073

Device Name: Clever Chek TD-3250 Blood Glucose and Blood Pressure Measurement System

Indications For Use:

The Clever Chek TD-3250 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 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 a 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 system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pluse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4 inches to ~ 13.8 inches.

Prescription Use (Part 21 CFR 801 Subpart D)

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Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Carol C. Benson
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K061073