# K173139: Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus

- Pathway: 510(k) (Traditional)
- Applicant: Bionime Corporation
- Decided: Jun 19, 2018 after 263 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170143: GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,, Bionime Corporation (2017) Summary page 6.

## Indications for use
Rightest Blood Glucose Monitoring System Wiz 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 Wiz 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). Rightest Blood Glucose Test Strip Wiz is used with Rightest Wiz Blood Glucose Meter for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Rightest Blood Glucose Monitoring System Wiz Plus 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 Wiz Plus 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). Rightest Blood Glucose Test Strip Wiz is used with Rightest Blood Glucose Meter Wiz Plus for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm.

Source page: https://510kreport.com/device/K173139
Methodology: https://510kreport.com/methodology