DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM

K072854 · Tyson Bioresearch, Inc. · NBW · Jun 30, 2008 · Clinical Chemistry

Device Facts

• Record ID: K072854
• Device Name: DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Tyson Bioresearch, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.

Device Story

System measures glucose in capillary whole blood via test strips; intended for home or clinical use. Operates via electrochemical biosensor technology; converts blood glucose concentration into electrical signal; displays quantitative glucose result. Used by patients or healthcare professionals to monitor diabetes management. Not for diagnosis or neonatal use.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Electrochemical glucose monitoring system; utilizes test strips for in vitro diagnostic use; measures capillary whole blood from fingertip, palm, or forearm; intended for quantitative glucose measurement.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm in persons with diabetes or clinical settings to monitor diabetes control. Not for diagnosis/screening of diabetes or neonatal testing. Alternative site testing restricted to steady-state 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

Image /page/0/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 3 0 2008

Tyson Bio Rescach, Inc.. c/o Dr. Wen-Hai Tsai (Simon Tsai) Official Correspondent 5F No. 22, Ke E Road III Science-Based Industrial Park Chu-Nan, Miao-Li County 350 Taiwan

k072854 Re:

> Trade Name: Diachex Basic Blood Glucose Monitoring System, Diachex Superb, BloodGlucose Monitoring System, Diachex Vigor Blood Glucose Monitoring Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: June 19, 2008 Received: June 19, 2008

Dear Dr. Tsai:

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 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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## Indication for Use

510(k) Number (if known): K072854

DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Device Name: Blood Glucose Monitoring System

Indication For Use:

The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.

Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 4079854