# K231679: CONTOUR® PLUS BLUE Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Ascensia Diabetes Care
- Decided: Feb 23, 2024 after 259 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: 8 generations back to K030531 (2003). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193407: Contour® next GEN Blood Glucose Monitoring System, Ascensia Diabetes Care (2021) Summary page 4.

## Indications for use
The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood glucose test strips and the Contour® Diabetes app. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® PLUS BLUE 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 in monitoring the effectiveness of a diabetes control program. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The CONTOUR® PLUS blood glucose test strips are for use with the CONTOUR® PLUS BLUE meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips. The system is intended for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K231679
Methodology: https://510kreport.com/methodology