# K151100: U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Sep 29, 2015 after 158 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K072784 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090188: U-Right TD-4227 NO Coding Blood Glucose Monitoring System, Model TD-4222, Taidoc Technology Corporation (2009) Summary page 5.

## Indications for use
The U-RIGHT TD-4116 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-RIGHT TD-4116 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. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates. The alternative site testing in this system can be used only during steady-state blood glucose conditions (when glucose is not changing rapidly). The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by professionals testing with capillary whole blood samples. The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by health care professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates. The system is only used with single-use, auto-disabling lancing devices. The alternative site testing in this system can be used only during steady-state blood glucose conditions (when glucose is not changing rapidly).

Source page: https://510kreport.com/device/K151100
Methodology: https://510kreport.com/methodology