# K101509: U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272 Blood Glucose Monitoring System - Pathway: 510(k) (Traditional) - Applicant: Taidoc Technology Corporation - Decided: Jun 27, 2011 after 391 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: 3 generations back to K070472 (2007). 3 ancestors in all. 6 later devices descend from it; 4 cite it directly. 0 of 10 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K094005: Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora G31B/TD-4256B Blood Glucose Monitoring System, Taidoc Technology Corporation (2010) Summary page 6. ## Most influential descendants - K143467: FORA GD43 Blood Glucose Monitoring System (2015), 1 descendant of its own - K113307: GL Goodlife Series Blood Glucose Monitoring Sysmtem (2012), 1 descendant of its own - K173505: FORA GTel Blood Glucose Monitoring System (2018), 0 descendants of its own - K162382: Smart Dongle Blood Glucose Monitoring System (2017), 0 descendants of its own - K140150: Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30 (2015), 0 descendants of its own ## Indications for use The U-Right TD-4279A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-Right TD-4279A 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 neonatal use. The U-Right TD-4279 A Test Strips are for use with the U-Right TD-4279A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The U-Right TD-4279B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-Right TD-4279B 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 neonatal use. The U-Right TD-4279B Test Strips are for use with the U-Right TD-4279B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The FORA GD4Oa/TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The FORA GD4Oa/TD-4272A 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 neonatal use. The FORA GD4Oa/TD-4272A Test Strips are for use with the FORA GD4Oa / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The FORA GD4Ob/TD-4272B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The FORA GD4Ob/TD-4272B 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 neonatal use. The FORA GD4Ob/TD-4272B Test Strips are for use with the FORA GD4Ob/TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The U-Right TD-4279A MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The U-Right TD-4279A MULTI Test Strips are for use with the U-Right TD-4279A MULTI Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips. The U-Right TD-4279B MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The U-Right TD-4279B MULTI Test Strips are for use with the U-Right TD-4279B MULTI Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips. The FORA Wisdom GD4Oa/TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The FORA Wisdom GD4Oa / TD-4272A Test Strips are for use with the FORA Wisdom GD4Oa / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips. The FORA Wisdom GD4Ob/TD-4272B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The FORA Wisdom GD4Ob/TD-4272B Test Strips are for use with the FORA Wisdom GD4Ob/TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips. Source page: https://510kreport.com/device/K101509 Methodology: https://510kreport.com/methodology