# K192220: ReliOn Premier Classic Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: I-Sens, Inc.
- Decided: Dec 13, 2019 after 120 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ReliOn™ Premier Classic Blood Glucose Monitoring System consists of the The ReliOn™ Premier Classic Blood Glucose Meter and the ReliOn™ Premier Blood Glucose Test Strips. The ReliOn™ Premier Classic Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternate sites such as the forearm, palm, thigh, and calf. Alternate site testing should be used only during steady-state blood glucose conditions. The ReliOn™ Premier Classic 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 system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

Source page: https://510kreport.com/device/K192220
Methodology: https://510kreport.com/methodology