# K080273: AB-Trol and Private Label Glucose Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics Texas, Inc.
- Decided: Aug 8, 2008 after 189 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: 7 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)
- K062347: Ascensia Breeze 2 Blood Glucose Monitoring System, Bayer Healthcare, LLC (2006) Summary page 1.
- K060426: Liberty Glucose Normal Control Solutions, Model 2120041, Liberty Healthcare Group, Inc. (2006) Summary page 1.

## Indications for use
For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the BREEZE 2 Blood Glucose Monitor.

Source page: https://510kreport.com/device/K080273
Methodology: https://510kreport.com/methodology