# K173638: Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus

- Pathway: 510(k) (Traditional)
- Applicant: Bionime Corporation
- Decided: Aug 17, 2018 after 266 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 K070585 (2007). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140210: Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720, Bionime Corporation (2014) Summary page 9.

## Most influential descendants
- K231192: RIGHTEST Blood Glucose Monitoring System Max Tel (2024), 1 descendant of its own
- K240637: RIGHTEST Blood Glucose Monitoring System Max Tel (2024), 0 descendants of its own

## Indications for use
Rightest Blood Glucose Monitoring System Max 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. It is intended to be used by a single person and should not be shared. Rightest Blood Glucose Monitoring System Max 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 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 Monitoring System Max is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max. Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function 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. It is intended to be used by a single person and should not be shared. Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function 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 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 Monitoring System Max Plus is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max Plus. GE Blood Glucose Monitoring System Max 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. It is intended to be used by a single person and should not be shared. GE Blood Glucose Monitoring System Max 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 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 GE Blood Glucose Monitoring System Max is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max. GE Blood Glucose Monitoring System Max Plus with Bluetooth function 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. It is intended to be used by a single person and should not be shared. GE Blood Glucose Monitoring System Max Plus with Bluetooth function 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 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 GE Blood Glucose Monitoring System Max Plus is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max Plus.

Source page: https://510kreport.com/device/K173638
Methodology: https://510kreport.com/methodology