ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222

K042005 · Taidoc Technology Corporation · NBW · Aug 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042005
• Device Name: ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 27, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Achtung TD-4207 / Clever Chek TD-4209 / Clever Chek TD-4222 Glucose Test Systems are intended for use in the quantitative measurement of glucose in whole blood from the finger. They are intended for use by healthcare professionals and people with diabetes as an aid in monitoring the effectiveness of diabetes control programs. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

Device Story

Glucose test systems (Achtung TD-4207, Clever Chek TD-4209, TD-4222) measure glucose levels in capillary whole blood samples obtained from fingersticks. Systems utilize electrochemical biosensor technology to quantify glucose concentration. Designed for use by healthcare professionals and patients in clinical or home settings. Output provides numerical glucose concentration values to assist in monitoring diabetes management. Results aid in assessing effectiveness of diabetes control programs; not intended for diagnostic or screening purposes.

Clinical Evidence

No clinical data provided; substantial equivalence based on design control activities, risk analysis, and verification/validation of modified features.

Technological Characteristics

Electrochemical glucose test system. Measures glucose in capillary whole blood. Class II device (Product Codes: NBW, CGA).

Indications for Use

Indicated for the quantitative measurement of glucose in capillary whole blood by people with diabetes at home or in clinical settings as an aid to monitor the effectiveness of diabetes control.

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

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#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# AUG 2 7 2004

Shu-Mei Wu, Ph.D Project Manager TaiDoc Technology Corporation 4F, 88, Sec.1, Kwang Fu Road San Chung, Taipei, China (Taiwan) 241

Re: k042005

Ro42009
Trade/Device Name: Achtung TD-4207/ Clever Chek TD-4209/ Clever Chek TD-4222 Glucose Test Systems Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: August 23, 2004 Received: August 23, 2004

Dear Dr. Shu-Mei Wu,

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 for ass stated in the energent in 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, de Hoos mat have over it at 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 r ou may, diereleve, mains 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 n may of be our 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 r rease be devilod that i be read on that your device complies with other requirements of the Act that I Drines Internand regulations administered by other Federal agencies. You must or any 1 vith all the Act's requirements, including, but not limited to: registration and listing (21 compt) with7); 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 ins icter will anow you to ought tinding of substantial equivalence of your device to a legally prematication. The 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 destions on the promotion and advertising of your device, please contact the Office of on questions on the promotion and Safety at [phone]. Also, please note the In v tr o Diagnostic Do researce to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu thay obtain other general members one 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,

Jean M. Cooper, MS, DVM.

Jean 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: K042005

Device Name: Achtung TD-4207 I Clever Chek TD-4209 / Clever Chek TD-4222 Glucose Test Systems

Indications For Use:

The Achtung TD-4207 I Clever Chek TD-4209 / Clever Chek TD-4222 Glucose Test Systems are intended for use in the quantitative measurement of glucose in whole oystems and mentabul for . They are intended for use by healthcare professionals and blood taxon from the finger. They me as an aid in monitoring the effectiveness of poople will alle too rem. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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)
Division Sign-Off

Office of in Vitro Dlagnostle Device Evaluation and Safet

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510(k) K042005