# K083549: Abt Glucose Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: American Biological Technologies, Inc.
- Decided: Dec 22, 2008 after 21 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). 28 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031260: Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005, Abbott Diabetes Care, Inc. (2003) Summary page 1.
- K060481: Liberty Glucose Control Solution, Liberty Healthcare Group, Inc. (2006) Summary page 1.

## Most influential descendants
- K102260: Fdi Glucose Control Solutions (2010), 1 descendant of its own
- K103450: Fdi Glucose Control Solution for Freestyle (2011), 0 descendants of its own

## 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 FreeStyle and FreeStyle Lite Blood Glucose Monitors.

Source page: https://510kreport.com/device/K083549
Methodology: https://510kreport.com/methodology