# K170464: StatStrip Xpress Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Nov 7, 2017 after 265 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 K070255 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160156: StatStrip Xpress Blood Glucose Monitoring System, Nova Biomedical Corporation (2016) Summary page 4.

## Indications for use
The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates. The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips. • The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use).

Source page: https://510kreport.com/device/K170464
Methodology: https://510kreport.com/methodology