# K151164: Assure Prism multi Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: I-Sens, Inc.
- Decided: Aug 7, 2015 after 98 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: 5 generations back to K024194 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131419: Acura Plus Multi Blood Glucose Monitoring System, I-Sens, Inc. (2013) Summary page 4.

## Indications for use
The Assure® Prism multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites (forearm, palm, thigh, and calf). Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for use outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes. Assure® Prism multi Blood Glucose Test Strips are for use with the Assure® Prism multi blood glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

Source page: https://510kreport.com/device/K151164
Methodology: https://510kreport.com/methodology