# K133522: Rightest Diabetes Management Software and Adapter (Existing Cleared K113007),Rightest New Adapters-3,GE Diabetes Managem - Pathway: 510(k) (Traditional) - Applicant: Bionime Coporation - Decided: Apr 17, 2014 after 153 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: 7 generations back to K024194 (2003). 10 ancestors in all. No later device cites it as a predicate yet. 0 of 11 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K110737: Rightest Blood Glucose Monitoring System GM700, Bionime Corporation (2012) - K123008: Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose Monitoring System Rightest Blood Glucose Monitorin, Bionime Corporation (2013) Summary page 6. - K120423: Bionime Rightest Blood Glucose Monitoring System, Model GM650, Bionime Corporation (2012) Summary page 6. - K062567: Rightest Blood Glucose Monitoring System, Bionime Corporation (2007) Summary page 6. - K113007: Bionime Diabetes Management System VI.0, Bionime Corporation (2012) ## Indications for use The GE Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from the following glucose meters: GEIOO0 Blood Glucose Monitoring System with GE PC Link Adaptor (GE GP5SO), GE300 Talking Blood Glucose Monitoring System with GE PC Link Adaptor for GE300 (GE GP300) and GE200 Blood Glucose Monitoring System with GE PC Link Adaptor (GE GPSSO) or GE Bluetooth PC Link (GE GP700) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users profile and data. The GE Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed health care professional. The Rightest Blood Glucose Monitoring System GM300 is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetes at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood fromi the fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring System 0M300. This device is not intended for testing neonate blood samples. Special conditions for use statement(s): Rightest System provides plasma equivalent results. The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM700 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. The Rightest Blood Glucose Monitoring System GM700 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Rightest Blood Glucose Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Bionime Rightest Diabetes Management System is Mnover-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from the following glucose meters: Rightest Blood Glucose Monitoring System GM550 and GM25O with Rightest PC Link Adaptor (GPSSO), Rightest Blood Glucose Monitoring System GM700 with Rightest PC Link Adaptor (0P550) or Rightest Bluetooth PC Link (GP700), Rightest Blood Glucose Monitoring System GM650 with Rightest PC Link Adaptor for GM650 (GP6SO), and Rightest Blood Glucose Monitoring System GM300 with Rightest PC Link Adaptor for GM300 (GP300) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data. The Bionime Rightest Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional. The GE200 Blood Glucose Monitoring System is intended to be used for the quatiutative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the Fingertips, forearm or palm. The GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Thre GE200 Blood Glucose Systemu is intended for self testing outside the body (in vitro diagnostic use) by peopfe with diabetes at home as an aid to mionitor the effectiveness of diabetes control. The GE3200 Blood Glucose Monitoring System should not bc used for the diagnosis of. or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The GE200 Blood Glucose Test Strips are for use wvith thie GE200 Blood Glucose Mleter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. forearm or palm. The GE300 Talking 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, forearm or palm. The GE300 Talking Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The GE300 Talking 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. The 08300 Talking Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The GE300 Blood Glucose Test Strip is for use with the GE300 Talking Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forea~n or palm. The Rightest Blood Glucose Monitoring System 0M650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM650 is intended to be used by a single person and should not be shared, The Rightest Blood Glucose Monitoring System GM65O 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. The Rightest Blood Glucose Monitoring System GM650 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Rightest Blood Glucose Test Strips GS650 ame for use with the Rightest Blood Glucose Meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. Source page: https://510kreport.com/device/K133522 Methodology: https://510kreport.com/methodology