# K123612: Fdi Glucose Control Solution for Use with Accu-Chek Aviva

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Jan 17, 2013 after 55 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
Longest line of descent: 2 generations back to K010362 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043474: Accu-Chek Aviva System, Roche Diagnostics Corp. (2005) Summary page 1.

## Indications for use
The FDI Glucose Control Solution is intended for use with Aviva Plus test strip when used on the Accu-Chek® Aviva blood glucose meter. The control solution is used with the Aviva Plus test strips to check that the meter and test strips are working together properly.

Source page: https://510kreport.com/device/K123612
Methodology: https://510kreport.com/methodology