# K090943: Abt Glucose Control Solution, Model: 2120089

- Pathway: 510(k) (Traditional)
- Applicant: American Biological Technologies, Inc.
- Decided: May 27, 2009 after 54 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052762: Liberty Blood Glucose Monitoring System, Model 8000-0067, Agamatrix, Inc. (2006) Summary page 1.
- K063855: Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution, Model 2120047, Liberty Healthcare Group, Inc. (2007) 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 Agamatrix WaveSense Presto Blood Glucose Monitor.

Source page: https://510kreport.com/device/K090943
Methodology: https://510kreport.com/methodology