EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST

K062235 · Taidoc Technology Corporation · NBW · Sep 19, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062235
• Device Name: EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The easy check TD-4209/Clever Chek TD-4222/Clever Chek TD-4225/Clever Chek TD-4226 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 the easy check TD-4209/Clever Chek TD-4222/Clever Chek TD-4225/Clever Chek TD-4226 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Device Story

System comprises blood glucose meter, test strips, control solutions, and lancet device; measures glucose in capillary whole blood via amperometric assay. User applies blood sample to test strip; glucose oxidase enzyme reacts with glucose to produce electrical current proportional to concentration; meter converts current to glucose value. Used by healthcare professionals and patients at home for diabetes management. Provides quantitative results to aid in monitoring diabetes control programs. Requires code strip for batch calibration. Performance verified against YSI-2300 reference method; supports alternative site testing (palm, forearm, upper-arm, calf, thigh) during steady-state conditions.

Clinical Evidence

Bench testing only. Precision evaluated using control solutions and venous whole blood (CV% 1.60-3.98%). Linearity demonstrated across 20-600 mg/dL range (r=0.9896). Method comparison (N=120 finger; N=100 per AST site) against YSI-2300 reference method showed 95%+ of results within ISO 15197 accuracy requirements (±15 mg/dL for <75 mg/dL; ±20% for ≥75 mg/dL). Altitude and reducing substance interference studies confirmed equivalence to predicate.

Technological Characteristics

Electrochemical glucose test system; capillary whole blood sample; handheld meter form factor; battery-powered; quantitative measurement.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from finger, palm, forearm, upper-arm, calf, and thigh. Intended for healthcare professionals and patients with diabetes mellitus for monitoring diabetes control programs. Not for neonates, diagnosis, or screening. Alternative site testing restricted to steady-state blood glucose conditions.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Pi-Shiou Li TaiDoc Technology Corporation 4F, No. 88, Sec. 1, Kwang-Fu Rd. San-Chung, Taipai County Taiwan

SEP 1 9 2006

Re: k062235

Trade/Device Name: easy check TD-4209, Clever Chek TD-4222, Clever Chek TD-4225, Clever Chek TD-4226 Blood Glucose Monitoring System Regulation Number: 21 CFR § 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: July 31, 2006 Received: August 3, 2006

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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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,

Alberto G

Alberto Gutierrez, Ph.D. 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: 长0622 35

Device Name: easy check TD-4209, Clever Chek TD-4222, Clever Chek TD-4225, Clever Chek TD-4226 Blood Glucose Monitoring System

Indications for Use:

The easy check TD-4209/Clever Chek TD-4222/Clever Chek TD-4225/Clever Chek TD-4226 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 the easy check TD-4209/Clever Chek TD-4222/Clever Chek TD-4225/Clever Chek TD-4226 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

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

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

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

ice of In Vitro Diagnostic I Evaluation and Safety

K062235

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