TAIDOC CHECK

K041107 · Taidoc Technology Corporation · NBW · Jun 18, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041107
• Device Name: TAIDOC CHECK
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Taidoc Check Blood Glucose test system is intended for use in the quantitative measurement of glucose in whole blood taken 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 diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

System measures glucose in capillary whole blood via electrochemical biosensor; user applies fingerstick sample to test strip; glucose oxidase enzyme reaction generates electrical current proportional to glucose concentration; meter converts current to concentration value; used by patients at home or healthcare professionals in clinics; provides quantitative results to aid diabetes management; results stored in meter memory; calibration via code strip.

Clinical Evidence

Performance evaluated in laboratory and clinical settings by both healthcare professionals and lay users. Studies demonstrated satisfactory performance for the intended use.

Technological Characteristics

Electrochemical meter with dry reagent biosensor test strips. Quantitative measurement based on current proportional to glucose concentration in fresh whole blood or control solutions.

Indications for Use

Indicated for quantitative blood glucose monitoring in patients with diabetes mellitus; for use by healthcare professionals and patients at home; not for neonates; not for diagnosis or screening.

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)

Submission Summary (Full Text)

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K041107

JUN 1 8 2004

# 510 (k) Summary

Page 1-of-2

1. Submitter Information

| Contact person | Shu-Mei Wu |
|----------------|-----------------------------------|
| Address | 4F, No. 88, Sec. 1, Kwang-Fu Rd., |
| | San-Chung, Taipei County, Taiwan |
| Phone | [phone] |
| FAX | [phone] |
| E-mail | [e-mail] |
| Date Prepared | April 23th , 2004 |

2. Name of Device

| Trade Names | TAIDOC CHECK Glucose Test System |
|---------------------------|------------------------------------------------|
| Common Names/Descriptions | Blood Glucose Meter |
| Common Names/Descriptions | Blood Glucose Test Strips |
| Classification Names | Class II devices |
| Classification Names | (21 CFR Section 862.1345, Glucose Test System) |

3. Predicate Device

| Trade/Proprietary Name: | GLUCOMETER ELITE Diabetes Care System |
|-------------------------|---------------------------------------|
| Common/Usual Name: | Blood Glucose Meter |
| Common/Usual Name: | Blood Glucose Test Strips |
| Manufacturer | Bayer Diagnostics |
| 510 (k) Number | K020208 |

### 4. Device Description

The TAIDOC CHECK glucose test 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.

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Page 2-of-2

#### 5. Intended Use

The TAIDOC CHECK glucose test 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).

### 6. Comparison to Predicate Device

The TAIDOC CHECK glucose test system has equivalent technological characteristics as the GLUCOMETER ELITE Diabetes Care System (K020208). The TAIDOC CHECK glucose test system also has the same intended use as the GLUCOMETER ELITE Diabetes Care System.

### 7. Performance Studies

The performance of the TAIDOC CHECK glucose test system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the TAIDOC CHECK glucose test system is suitable for its intended use.

#### 8. Conclusion

The TAIDOC CHECK glucose test system demonstrates satisfactory performance and is suitable for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 8 2004

Mr. Shu-Mei Wu Project Manger TaiDoc Technology Corporation 4F, NO. 88, Sec.1, Kwang-Fu Rd. San-Chung, Taipei County 241 Taiwan

Re: k041107

K041107
Trade/Device Name: TAIDOC CHECK Blood Glucose Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: June 2, 2004 Received: June 2, 2004

Dear Mr. Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the endrosare) to regard) the enactment date of the Medical Device Amendments, or to commerce processified in accordance with the provisions of the Federal Food, Drug, devices that have been receasined in avere approval of a premarket approval application (PMA). and Costietle Ace (110) that to hevice, subject to the general controls provisions of the Act. The r ou may, dicrerore, mains of the Act include requirements for annual registration, listing of general oonlines provision 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 it may be subject to such adultions controllar Disting Carry of College of Colors 800 to 895. In addition, FDA can be found in The announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I Dris issuanted vice complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must or any I cacal statutes and regainents, 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 his letter will anow you to ocgin makeming of substantial equivalence of your device to a legally prematicated predicated. The Pression 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 internance advertising of your device, please contact the Office of of questions on the promotion and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the 1 ou may oount other generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sean M. Cooper, US, DVM.

Yean 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 (if known):_K041107

Device Name: TAIDOC CHECK Blood Glucose Test System

Indications for Use:

The TAIDOC CHECK Blood Glucose test system is intended for use in the quantitative measurement of glucose in whole blood taken 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 diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR (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)

Carol C. Benson
Division Sign-Off

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510(k) K 04 1107