CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING

K073494 · Taidoc Technology Corporation · NBW · Apr 2, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073494
• Device Name: CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the modified device as described in its labeling has not changed.

Device Story

Blood glucose monitoring systems (meters) measure glucose levels in capillary whole blood samples. Modification involves software updates to the TD-4209, TD-4226, TD-4222, TD-4225, and TD-4207 meters. For TD-4209 and TD-4226, software now displays internal meter code for user verification against test strip vial codes. For TD-4222, TD-4225, and TD-4207, software eliminates manual user coding by utilizing an internal meter code. Devices are used by patients for self-monitoring of blood glucose. Output is a numerical glucose concentration displayed on the meter screen, assisting patients and clinicians in diabetes management.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Glucose monitoring meters utilizing electrochemical sensing technology. Modifications are limited to firmware/software logic regarding meter coding (displaying internal code or removing manual coding requirement).

Indications for Use

Indicated for the quantitative measurement of glucose in capillary whole blood as an aid in monitoring the effectiveness of diabetes control programs.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Taidoc Technology Corporation c/o Yuhua Chen 6F, No. 127, Wugong 2nd Rd. Taipei County, China (Taiwan) 248

APR - 2 2008

Re: k073494

> Trade/Device Name: ACHTUNG TD-4207, Clever Check TD-4209, Clever Chek TD-4222, Clever Chek TD-4225, Clever Chek TD-4226 Blood Glucose Monitoring Systems Regulation Number: 21 CFR8862,1345

Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: March 19, 2008 Received: March 20, 2008

Dear Yuhua Chen:

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).

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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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Yean 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 2

## Indications for Use

## 510(k) Number:

Device Name: Achtung TD-4207 no code, Clever Chek TD-4209 one-code, Clever Chek TD-4222 no code, Clever Chek TD-4225 no code, Clever Chek TD-4226 one-code Blood Glucose Monitoring System

Indications for Use:

The Achtung TD-4207 no code/Clever Chek TD-4209 one-code/Clever Chek TD-4222 no code/Clever Chek TD-4225 no code/Clever Chek TD-4226 one-code 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, and is not intended for use on neonates.

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

Prescription Use _ (Part 21 CFR 801 Subpart D)

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

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

AND/OR

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

Carol C. Benson

**Sign**

e of In Vitro Diagnostic L muation and Safely

K073494

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