(125 days)
Not Found
No
The description focuses on electrochemical measurement of glucose and does not mention any AI or ML components.
No.
The device measures glucose levels as an aid in monitoring diabetes, but it does not directly treat or cure the condition.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is not intended for the diagnosis of or screening for diabetes mellitus." While it measures glucose, its purpose is for monitoring effectiveness of a diabetes control program, not for initial diagnosis.
No
The device description explicitly states it is a "dry reagent biosensor (test strips)" and is used with "Blood Glucose Meters and Blood Glucose plus Blood Pressure Monitors," indicating it is a physical component and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in fresh capillary whole blood". This is a measurement performed in vitro (outside the body) on a biological sample (blood).
- Device Description: The device description details an "electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing". This describes a system designed to analyze a biological sample in vitro.
- Function: The core function is to measure a substance (glucose) in a biological sample (blood) to provide information about a person's health status (diabetes control). This is the fundamental purpose of an IVD.
The fact that it's used to monitor diabetes control and is not for diagnosis or screening doesn't change its classification as an IVD. It's still performing a diagnostic measurement in vitro.
N/A
Intended Use / Indications for Use
The TaiDoc Pro I Glucose Test Strip 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. The test strips are for use with Clever Chek TD-4222, Clever Chek TD-4230, Clever Chek TD-4231 Blood Glucose Meters and Clever Chek TD-3250C, and Fora Comfort 2 in 1 TD-3260 Blood Glucose plus Blood Pressure Monitors Only. 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.
Product codes
NBW, LFR
Device Description
The TaiDoc Pro I Glucose Test Strip is designed to quantitatively measure the concentration of glucose in whole blood. The test principle of the system utilize an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, palm, forearm, upper-arm, calf, thigh
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
healthcare professionals and people with diabetes mellitus at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of TaiDoc Pro | Glucose Test Strip was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1345 Glucose test system.
(a)
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.(b)
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.
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510 (k) Summary
DEC 0 4 2008
Page 1-of-2
- Submitter Information Company name Contact person Address
Phone FAX E-mail Date Prepared
- Name of Device Trade Names Common Names/Descriptions Classification Names
Product Code
- Predicate Device Trade/Proprietary Name: Common/Usual Name: Manufacturer 510 (k) Number
TaiDoc Technology Corporation Yuhua Chen 6F, No. 127, Wugong 2nd Rd, Wugu Township, Taipei County, 24888, Taiwan (886-2) 6625-8188 (886-2) 6625-0288 erica@taidoc.com July 30th , 2008
TaiDoc Pro I Glucose Test Strip Blood Glucose Test System Class II devices (21 CFR Section 862.1345, Glucose Test System) NBW and LFR
Accu-CheK Go Test System
Blood Glucose test system Roche Diagnostics K040796
1
4. Device Description
The TaiDoc Pro I Glucose Test Strip is designed to quantitatively measure the concentration of glucose in whole blood. The test principle of the system utilize an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of qlucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
5. Intended Use
The TaiDoc Pro I Glucose Test Strip 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. The test strips are for use with Clever Chek TD-4222, Clever Chek TD-4230, Clever Chek TD-4231 Blood Glucose Meters and Clever Chek TD-3250C, and Fora Comfort 2 in 1 TD-3260 Blood Glucose plus Blood Pressure Monitors Only. 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.
6. Comparison to Predicate Device
TaiDoc Pro 1 Glucose Test Strip has equivalent technological characteristics and the similar intended use as the Accu-Chek Go Test System (K040796).
7. Performance Studies
The performance of TaiDoc Pro | Glucose Test Strip was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use.
8. Conclusion
TaiDoc Pro I Glucose Test Strip demonstrates satisfactory performance and is suitable for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the body and wings.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
TaiDoc Technology Corporation c/o Yuhua Chen Assistant Manager, Regulatory Affairs 6F. No. 127. Wugong 2nd Road Wugu Township, Taipei County China (Taiwan) 248
DEC 0 4 2008
K082169 Re:
Trade/Device Name: TaiDoc Pro I Glucose Test Strips Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR Dated: October 31, 2008 Received: November 3, 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, 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).
3
Page 2 -
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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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.
Sean 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
4
Indications for Use
510(k) Number: K082169
Device Name: TaiDoc Pro | Glucose Test Strip
Indication For Use:
The TaiDoc Pro I Glucose Test Strip 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. The test strips are for use with Clever Chek TD-4222, Clever Chek TD-4230, Clever Chek TD-4231 Blood Glucose Meters and Clever Chek TD-3250C, and Fora Comfort 2 in 1 TD-3260 Blood Glucose plus Blood Pressure Monitors Only. 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.
And/Or
Prescription Use __ X (21 CFR Part 801 Subpart D) Over the Counter Use _ X (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)
CA
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082169
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