(113 days)
No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is a monitoring system that measures glucose levels, which helps in managing diabetes, but it does not directly treat or provide therapy for the condition.
No
Explanation: The device is explicitly stated as "not intended for the diagnosis of or screening for diabetes mellitus," indicating it is for monitoring purposes rather than initial diagnosis.
No
The device description explicitly states the system consists of a meter, test strips, and control solutions, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "It is intended for self testing outside the body (in vitro diagnostic use)..."
- Nature of the Test: The device measures glucose in a blood sample, which is a biological sample taken from the body and tested in vitro (outside the body).
- Purpose: The purpose is to aid in monitoring the effectiveness of diabetes control, which is a diagnostic purpose.
Therefore, based on the provided text, the U-RIGHT TD-4280 Blood Glucose Monitoring System is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The U-RIGHT TD-4280 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared.
The U-RIGHT TD-4280 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates. The meter contains speaking functions but is not intended for use by visually impaired users.
The U-RIGHT TD-4280 Blood Glucose Test Strips are for use with the U-RIGHT TD-4280 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
Product codes
NBW, LFR
Device Description
The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger (fresh capillary whole blood samples from the finger)
Indicated Patient Age Range
Not intended for use on neonates. Intended for use by people with diabetes.
Intended User / Care Setting
self testing outside the body (in vitro diagnostic use) by people with diabetes 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
A comparison of system accuracy performance demonstrated that the U-RIGHT TD-4280 Blood Glucose Monitoring System and the TD-4277 Blood Glucose Monitoring System are substantially equivalent.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the U-RIGHT TD-4280 Blood Glucose Monitoring System are equivalent to the predicate device.
Key Metrics
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.
0
APR 1 2 2012
Section 11. 510(k) Summary
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:
-
- Submitter's Identification:
TaiDoc Technology Corporation
- Submitter's Identification:
3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 248, Taiwan
Correspondent:
Meiru Li
Regulatory Affairs Specialist
Tel: +886-2-6625-8188 #6134
Fax: +886-2-6625-0288
Email: limeiru@taidoc.com.tw
Prepared date: December 19, 2011
-
- Device name:
்.
- Device name:
Proprietary name: U-RIGHT TD-4280 Blood Glucose Monitoring System
Regulatory information:
- Regulation section: 21 CFR 862.1345 Glucose Test System A.
Classification: Class II B.
LFR, Glucose Dehydrogenase, Glucose Product Code:
NBW, System, Test, Blood Glucose, Over the Counter
Clinical Chemistry (75) Panel: D.
1
3. Intended Use:
The U-RIGHT TD-4280 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared.
The U-RIGHT TD-4280 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates. The meter contains speaking functions
but is not intended for use by visually impaired users.
The U-RIGHT TD-4280 Blood Glucose Test Strips are for use with the U-RIGHT TD-4280 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
-
- Device Description:
The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.
- Device Description:
Substantial Equivalence Information: ડાં
A. Predicate device name: TD-4277 Blood Glucose Monitoring System
Predicate K number: K100322 B.
C. Comparison with predicate:
The modified U-RIGHT TD-4280 Blood Glucose Monitoring System has the following similarities to the predicate device:
트 same operating principle,
same fundamental scientific technology, 1
incorporate the same basic circuit design,
incorporate the same materials,
same shelf life
packaged using the same materials, and
manufactured by the same process.
2
The modifications encompass:
- Addition of the speaking function
- Modification in the physical appearance 트
- . Minor software modifications of the glucose meter
- 1 Change of the data transmission method from USB to RS-232
- Reduced the memory capacity from 1000 measurement to 450 measurement 1
- Labeling change due to the above modifications 0
· 6. Test Principle:
The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose dehydrogenase.
7. Performance Characteristics:
U-RIGHT TD-4280 Blood Glucose Monitoring System has the same performance characteristics as the predicate device.
A comparison of system accuracy performance demonstrated that the U-RIGHT TD-4280 Blood Glucose Monitoring System and the TD-4277 Blood Glucose Monitoring System are substantially equivalent.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the U-RIGHT TD-4280 Blood Glucose Monitoring System are equivalent to the predicate device. '
8. Conclusion:
Based on the information provided in this submission, the U-RIGHT TD-4280 Blood Glucose Monitoring System is substantially equivalent to the predicate TD-4277 Blood Glucose Monitoring System.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its head turned to the right, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the eagle. The eagle is depicted with flowing lines, giving it a sense of movement. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration
TAIDOC TECHNOLOGY CORPORATION C/O MEIRU LI 6F, NO. 127 WUGONG 2ND RD. WUGU TOWNSHIP NEW TAIPEI CITY CHINA (TAIWAN) 24888
10903 New Hampshire Avenue Silver Spring, MD 20993
APR 1 2 2012
Re: K113768
Trade Name: U-Right TD-4280 Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, LFR Dated: March 12, 2012 Received: March 15, 2012
Dear Meiru 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 Iİ (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).
4
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/Medical
Devices/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/Resourcesfor You/Industry/default.htm
Sincerely yours,
N.
Gary K. Haines, Ph.D.
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Attachment E.
Indications for Use
510(k) Number (if known):
Device Name: U-RIGHT TD-4280 Blood Glucose Monitoring System, model TD-4280
Indications for Use:
The U-RIGHT TD-4280 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared.
The U-RIGHT TD-4280 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates. The meter contains speaking functions but is not intended for use by visually impaired users.
The U-RIGHT TD-4280 Blood Glucose Test Strips are for use with the U-RIGHT TD-4280 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
(Part ) Prescription Use _____________________________________________________________________________________________________________________________________________________________ 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use _ X (21 CFR 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 (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_K1137
Attachment E.- 1