# K240637: RIGHTEST Blood Glucose Monitoring System Max Tel

- Pathway: 510(k) (Traditional)
- Applicant: Bionime Corporation
- Decided: Nov 4, 2024 after 243 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: 4 generations back to K070585 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231192: RIGHTEST Blood Glucose Monitoring System Max Tel, Bionime Corporation (2024) Summary page 6.

## Indications for use
RIGHTEST Blood Glucose Monitoring System Max Tel 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 Tel 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 Tel is comprised of the RIGHTEST Meter Max Tel and the RIGHTEST Blood Glucose Test Strip Max.

Source page: https://510kreport.com/device/K240637
Methodology: https://510kreport.com/methodology