# K151742: Contour Next Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare
- Decided: Sep 23, 2015 after 86 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Contour Next Control Solution: named in the summary without a submission number

## Indications for use
CONTOUR®NEXT control solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check to ensure that the Contour Next Blood Glucose Monitoring Systems are working properly.

Source page: https://510kreport.com/device/K151742
Methodology: https://510kreport.com/methodology