CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM

K073119 · Taidoc Technology Corporation · NBW · Mar 3, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073119
• Device Name: CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Clever Chek TD-4232 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. The alternative site testing in this system can be used only during steady-state blood glucose conditions. This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Device Story

System comprises blood glucose meter and dry reagent biosensor test strips; utilizes electrochemical method to measure glucose concentration in fresh capillary whole blood or control solutions. Current magnitude is proportional to glucose level; provides quantitative output. Used by patients with diabetes at home or healthcare professionals in clinical settings. Includes integrated speaker functionality providing step-by-step audio instructions to assist visually impaired users. Output used by patients/clinicians to monitor diabetes control program effectiveness.

Clinical Evidence

Performance evaluated in laboratory and clinical settings by healthcare professionals and lay users. Studies demonstrated system performance meets intended use requirements.

Technological Characteristics

Glucose oxidase amperometric biosensor. Measures electrical current proportional to glucose concentration. Dimensions/form factor: handheld meter. Connectivity: standalone. Power: battery-operated (implied). Calibration: single-code system. Software: embedded firmware for meter control and voice synthesis. Sterilization: not applicable (test strips). Standards: ISO 15197, CLSI EP9-A, ISO 14971.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from finger, palm, forearm, upper-arm, calf, or thigh. For use by healthcare professionals and patients with diabetes mellitus at home to monitor diabetes control. Not for diagnosis or screening of diabetes. Contraindicated for neonates, patients in shock, dehydrated, critically ill, or in hyperosmolar state.

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

• Clever Chek TD-4223 Blood Glucose Monitoring System (k063212)

Submission Summary (Full Text)

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K073/119

# 510 (k) Summary

1. Submitter Information Company name Contact person Address

Phone FAX E-mail

2. Name of Device Trade Names

Common Names/Descriptions

Classification Names

MAR - 3 2008

Page 1-of-3

TaiDoc Technology Corporation Erica Li 4F, No. 88, Sec. 1, Kwang-Fu Rd, San-Chung, Taipei County, 241, Taiwan (886-2) 6635-8080 (886-2) 6635-5959 [e-mail]

CLEVER CHEK TD-4232 Blood Glucose Monitoring System

Blood Glucose Meter Blood Glucose Test Strips Class II devices (21 CFR Section 862.1345, Glucose Test System)

3. Predicate Device Trade/Proprietary Name:

Common/Usual Name:

Manufacturer 510 (k) Number Clever Chek TD-4223 Blood Glucose Monitoring System Blood Glucose Meter Blood Glucose Test Strips TaiDoc Technology Corporation K063212

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#### 4. Device Description

CLEVER CHEK TD-4232 Blood Glucose Monitoring System consists of a meter 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.

#### 5. Intended Use

CLEVER CHEK TD-4232 Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood taken from the finger and the alternative sites 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 alternative site testing (the plam, the forearm, the upper arm, the calf and the thigh) in this system can be used only during steady-state blood glucose conditions.

This system contains speaker function which provides step by step instructions.

### 6. Comparison to Predicate Device

CLEVER CHEK TD-4232 Blood Glucose Monitoring System has equivalent technological characteristics as the Clever Chek TD-4223 blood glucose monitoring system (K063212). CLEVER CHEK TD-4232 Blood Glucose Monitoring System also has the same intended use as the lever Chek TD-4231 blood glucose monitoring system

### 7. Performance Studies

The performance of CLEVER CHEK TD-4232 Blood Glucose Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use.

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## 8. Conclusion

. .

CLEVER CHEK TD-4232 Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Taidoc Technology Corporation c/o Ms. Erica Li Management Representative 4F. 88. Sec. 1. Kawang Fu Road San Chung, Taipei County Taiwan 241 China

MAR - 3 2008

Re: k073119

Trade/Device Name: Clever chek model td-4232 blood glucose monitoring system Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: February 18, 2008 Received: February 20, 2008

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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Page 2 -

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 vours.

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

Jean 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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#### Attachment A

#### Indications for Use

510(k) Number: k073119

Device Name: CLEVER CHEK TD-4232 Blood Glucose Monitoring System

Indications for Use:

The CLEVER CHEK TD-4232 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.

The alternative site testing in this system can be used only during steady-state blood glucose conditions.

This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

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

Oa

Division Sign-Off

Office of In Vitro DiagnosticsDevice Evaluation and Safety

510(2) k073119