CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0

K070941 · Taidoc Technology Corporation · NBW · Jun 21, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070941
• Device Name: CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Clever Chek Health Care System Software is intended for use in home and clinical settings as an aid for people with diabetes and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.

Device Story

Clever Chek Health Care System Software is an optional data management accessory for specific TaiDoc blood glucose and blood pressure monitoring devices. It functions by transferring stored test data from the meter's memory to a computer. Used in home and clinical settings by patients and healthcare professionals, the software provides a platform to review, analyze, and evaluate historical test results. This enhanced data management capability assists in health management by allowing users and clinicians to visualize trends in glucose and blood pressure data. The software does not modify the transferred data, ensuring integrity of the original test results.

Clinical Evidence

Bench testing only. Validation included verification of hardware data transfer via cable, software functionality, and user evaluation to confirm the system meets its intended use.

Technological Characteristics

Software-based data management system. Operates via data transfer from compatible blood glucose and blood pressure meters to a computer. Connectivity via cable. No modification of transferred data allowed. Rule-based data processing for historical review and analysis.

Indications for Use

Indicated for users of Clever Chek blood glucose meters, blood glucose plus blood pressure monitors, and blood pressure monitors in home and clinical settings to facilitate review, analysis, and evaluation of historical test results for health management.

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

• Camit Diabetes Management Software (k001907)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510 (k) Summary

K070941

JUN 2 1 2007

Page 1-of-2

1. Submitter Information Company name Contact person Address

Phone FAX E-mail Date Prepared

2. Name of Device Trade Names

Common Names Classification Names and Regulations

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] Mar 30th , 2007

Clever Chek Health Care System Software Data management software

a) Calculator/data processing module for clinical use, Class I, 21CFR862.2100 b) Glucose Test System, Class II, 21CFR862.1345 c) Noninvasive Blood Pressure Measurement System, Class II, 21CFR870.1130,

3. Predicate Device Trade/Proprietary Name: Common/Usual Name: Submitter 510 (k) Number

Camit Diabetes Management Software Data management software Roche Diagnostics Corporation K001907

{1}------------------------------------------------

## 4. Device Description

The Clever Chek Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a)Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.

### 5. Intended Use

The Clever Chek Health Care System Software is intended for use in home and clinical settings as an aid for people with diabetes and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.

### 6. Comparison to Predicate Device

The Clever Chek Health Care System Software is substantially equivalent to the Camit Diabetes Management Software (K001907). Both management software programs can be described as follows:

- have the same intended use.

- data transferred from the device cannot be changed or modified in any way.

### 7. Performance Studies

Testing of Clever Chek Health Care System Software included validation of hardware (data transfer through the cable) software and user evaluation. It demonstrated that the system meets its intended use.

### 8. Conclusion

Clever Chek Health Care System Software demonstrates satisfactory performance and is suitable for its intended use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

TaiDoc Technology Corporation c/o Ms. Erica (Pi-Shiou) Li Management Representative 4F, No. 88, Sec. 1, Kwang-Fu Rd. San-Chung, Taipei County Taiwan 241

JUN 2 1 2007

k070941 Trade/Device Name: Clever Chek Health Care System Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, DXN Dated: March 30, 2007 Received: April 04, 2007

Dear Ms. Li:

Re:

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. Ilsting 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).

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin mains of substantial equivalence of your device to a legally promarket notification - 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, If you desire specific intoniation actuation of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the V III Diagnostic Dones Bradian by reference to premarket notification" (21CFR Part 807.97). Tou may obtain other general information on your responsibilities under the Act from the 1 ou may oounn only. Echerational 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.

Jéan 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

{4}------------------------------------------------

### Indications for Use

510(k) Number: K070941

Device Name: Clever Chek Health Care System Software

Indications for Use:

The Clever Chek Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.

The Clever Chek Health Care System Software is intended for use in home and clinical settings as an aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.

AND/OR

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (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)

CL

Page 1 of

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

510(k) k07099