TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277

K100322 · Taidoc Technology Corporation · NBW · Jun 28, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100322
• Device Name: TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

TD-4277 Blood Glucose Monitoring System, Model TD-4277 is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. It is intended for use by healthcare professionals and people with diabetes mellius 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. Professionals may use the test strips to test capillary and venous blood samples, but lay user may not test venous blood samples.

Device Story

System measures glucose in fresh capillary whole blood (fingerstick) or venous blood (professionals only). Uses amperometric technology with glucose dehydrogenase-FAD enzyme; chemical reaction generates electrical current proportional to glucose concentration. Meter displays results; stores up to 1000 measurements; transmits data to PC via USB. Used by patients at home or healthcare professionals in clinical settings. Provides quantitative glucose values to aid diabetes management. Benefits include monitoring effectiveness of diabetes control programs. System includes meter, test strips, control solutions, lancing device, and lancets.

Clinical Evidence

Laboratory and clinical studies performed to validate system performance. No specific numerical metrics (e.g., sensitivity, specificity) provided in summary; states performance meets intended use requirements.

Technological Characteristics

Electrochemical biosensor technology using glucose dehydrogenase. System includes meter, test strips, and control solutions. Class II device (Glucose Test System).

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from the finger for people with diabetes mellitus and healthcare professionals. Not for neonates, diagnosis/screening of diabetes, or use on critically ill, shock, dehydrated, hypotensive, or hyperosmolar patients.

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

• TaiDoc Pro I Glucose Test Strip (k082169)
• FORA G30 blood glucose monitoring system (k090187)

Submission Summary (Full Text)

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## 3. 510(k) Summary

# JUN 2 8 2010

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The Assigned 510(k) number is: K100322

1. Submitter's Identification:

TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan

Correspondence: Debra Liang Regulatory Affairs Specialist Tel: [phone] #1198 Fax: [phone] Email: [e-mail]

Date of preparation: February 1, 2010

- 2. Device name:
Proprietary name: TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277

Regulatory information:

| A. | Regulation section: 21 CFR § 862.1345, Glucose Test System<br>21CFR 862.1660 Quality control material (assayed and<br>unassayed). |
|----|-----------------------------------------------------------------------------------------------------------------------------------|
| B. | Classification: Class II (Glucose Test System)<br>Class 1 (Quality control material (assayed and<br>unassayed) (reserved) |
| C. | Product Code: NBW, System, Test, Blood Glucose, Over The Counter<br>LFR, glucose dehydrogenase, glucose |

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## JJX Single (Specified) Analyte Controls (Assayed and Unassayed)

Panel: 75, Clinical Chemistry - Glucose Test System

## 3. Intended Use:

TD-4277 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood 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.

Professionals may use the test strips to test capillary and venous blood samples, but lay user may not test venous blood samples

- 4. Device Description:
The kit of TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277 consists of: the meter with blood glucose measurement function, test strips and control solutions. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.

- 5. Substantial Equivalence Information:
- A. Predicate device name:

TaiDoc Pro I Glucose Test Strip, k082169

FORA G30 blood glucose monitoring system, k090187

B. Comparison with predicate:

The TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277 has the equivalent technological characteristics and the similar intended use as the predicate devices.

- 6. Test Principle:
For blood glucose, the detection and measurement is by an electrochemical biosensor technology using glucose dehydrogenase.

- 7. Performance Characteristics:
The laboratory and clinical studies for the performance of TD-4277 BLOOD

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GLUCOSE MONITORING SYSTEM MODEL TD-4277 demonstrated that the performance of this system meets its intended use.

- 8. Conclusion:
Based on the information provided in this submission, the TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277 is substantially equivalent to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Taidoc Technology Corporation c/o Debra Liang Regulatory Affairs Specialist 6f, No. 127, Wugong 2nd Rd, Wugu Township Taipei County. 248 TW - CHINA (TAIWAN)

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

JUN 2 8 2010

### Re: k100322

Trade/Device Name: TD-4277 Blood Glucose Monitoring System. Model 4277 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW, LFR, JJX Dated: June 25, 2010 Received: June 28, 2010

Dear: Ms. Liang:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, 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 G.

### Indications for Use

510(k) Number: K100322

Device Name: TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4277

Indications for Use:

TD-4277 Blood Glucose Monitoring System, Model TD-4277 is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. It is intended for use by healthcare professionals and people with diabetes mellius 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.

Professionals may use the test strips to test capillary and venous blood samples, but lay user may not test venous blood samples.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ 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 Device Evaluation and Safety (OVD)

Chris

**Division Sign-Off**

**Office of In Vitro Diagnostic Device Evaluation and Safety**

510(k) K/00322

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