# K163087: PixoTest Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Ixensor Company, Ltd.
- Decided: Nov 2, 2017 after 364 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: 6 generations back to K945887 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021827: Modification to Accu-Chek Active System, Roche Diagnostics Corp. (2002) Summary page 5.

## Indications for use
The PixoTest Blood Glucose Monitoring System is comprised of PixoTest Glucose Test Strip, PixoTest Uni-Clip, and the PixoHealth App as the display component of the system. The PixoTest Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. The PixoTest 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 for single person use only and should not be shared. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates.

Source page: https://510kreport.com/device/K163087
Methodology: https://510kreport.com/methodology