(168 days)
Not Found
No
The summary describes a standard electrochemical blood glucose monitoring system with a speaking function for accessibility. There is no mention of AI or ML in the intended use, device description, or performance study summary.
No
The device is intended for quantitative measurement of glucose to aid in monitoring the effectiveness of a diabetes control program, not for direct therapeutic intervention or treatment.
Yes
The device is described as aiding in "monitoring the effectiveness of diabetes control program" and explicitly states "It is not intended for the diagnosis of or screening for diabetes mellitus". While it measures glucose, its intended use is for monitoring, not initial diagnosis.
No
The device description explicitly states that the system consists of a meter and test strips, which are hardware components.
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 description details the use of a "dry reagent biosensor (test strips)" and an "electrochemical method-based meter". These are components and methods commonly used in IVD devices for analyzing biological samples.
- Function: The core function is to measure a substance (glucose) in a biological fluid (blood) to provide information about a person's health status (diabetes control). This is a defining characteristic of an IVD.
The fact that it's used by healthcare professionals and individuals at home for monitoring diabetes control further supports its classification as an IVD.
N/A
Intended Use / Indications for Use
U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood taken from the finger and the alternative sites for self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities. Testing is done outside the body (in vitro diagnostic use).
The alternative site testing (the plam, the forearm, the upper arm, the calf and the thigh) in this system can be used only during steady-state blood glucose conditions.
This system contains speaker function which provides step by step instructions.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes 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
fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh.
Indicated Patient Age Range
The device is not intended for use on neonates.
Intended User / Care Setting
self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities.
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)
Since the change between the predicate and proposed devices is only in the brand name, the performance data of U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System can be reference to K072784.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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JUL 1 3 2009
510 (k) Summary
Page 1-of-2
- Submitter Information Company name Contact person Address
Phone FAX E-mail
- Name of Device Trade Names
Common Names/Descriptions
Classification Names
- Predicate Device Trade/Proprietary Name:
Common/Usual Name:
Manufacturer 510 (k) Number
TaiDoc Technology Corporation Erica Li 6F, No. 127, Wugong 2nd Rd, Wugu Township, Taipei County, 248, Taiwan (886-2) 6625-8188 (886-2) 6625-0288 erica@taidoc.com.tw
U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System Blood Glucose Meter Blood Glucose Test Strips Class II devices (21 CFR Section 862.1345, Glucose Test System)
Clever Chek TD-4227 Blood Glucose Monitoring System Blood Glucose Meter Blood Glucose Test Strips TaiDoc Technology Corporation K072784
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Page 2-of-2
4. Device Description
U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes 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.
5. Intended Use
U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood taken from the finger and the alternative sites for self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities. Testing is done outside the body (in vitro diagnostic use).
The alternative site testing (the plam, the forearm, the upper arm, the calf and the thigh) in this system can be used only during steady-state blood glucose conditions.
This system contains speaker function which provides step by step instructions.
6. Comparison to Predicate Device
U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System has equivalent technological characteristics as the Clever Chek TD-4227 blood alucose monitoring system (K072784). U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System also has the same intended use as the Clever Chek TD-4227 blood glucose monitoring system
7. Performance Studies
Since the change between the predicate and proposed devices is only in the brand name, the performance data of U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System can be reference to K072784.
8. Conclusion
U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for its intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Taidoc Technology Corporation c/o Ms. Erica Li Management Representative 6F, No. 127, Wugong 2nd Road Wugu Township, Taipel County, China (Taiwan) 241
JUL 1 8 2009
Re: K090188
Trade Name: U-Right TD-4227 No Coding Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: May 21, 2009 Received: May 26, 2009
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 ( frecting 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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Page 2
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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
G.C.H.
Courtney C. Harper, Ph.D. Acting 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 3
Indications for Use
510(k) Number: K090188
Device Name: U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System
Indications for Use:
The U-RIGHT TD-4227 No Coding 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 this system can be used only during steady-state blood glucose conditions.
This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
Over-The-Counter Use AND/OR X Prescription Use X (Part 21 CFR 801 Subpart D) (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)
Page 1 of
Carol C. Bensen
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 8 of 21
510(k) K0%188