# K090628: Didget Blood Glucose Meter, Model 6181; Contour Blood Glucose Test Strips, Model 7080

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Dec 4, 2009 after 270 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: 1 generation back to K060470 (2006). 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)
- K062058: Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080, Bayer Healthcare (2006) Summary page 1.
- K060470: Ascensia Contour Blood Glucose Meter, Model 7151; Ascensia Microfill Reagent Strip, Model 7080, Bayer Healthcare (2006) Summary page 1.

## Indications for use
The Didget blood glucose monitoring system (meter, strips, and controls) is intended for self-testing by people with diabetes to monitor glucose concentrations in fresh capillary whole blood samples drawn from the fingertip only. It is intended for those ages four and older, with adult Supervision as needed. The Didget blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Source page: https://510kreport.com/device/K090628
Methodology: https://510kreport.com/methodology