# K113768: U-Right TD-4280 Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Apr 12, 2012 after 113 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- 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: 4 generations back to K031755 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100322: TD-4277 Blood Glucose Monitoring System, Model 4277, Taidoc Technology Corporation (2010) Summary page 2.

## 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. Itris intended to be used by a single person and should not be shared. The U-RIGI-T 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 contain s 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.

Source page: https://510kreport.com/device/K113768
Methodology: https://510kreport.com/methodology