# K091460: Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087

- Pathway: 510(k) (Traditional)
- Applicant: American Biological Technologies, Inc.
- Decided: Aug 6, 2009 after 80 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: 1 generation back to K080641 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080641: Trueresult Blood Glucose System E4H01-81, Home Diagnostics, Inc. (2008) 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 TRUEresuIt TM and TRUE2go TM Meters and TRUEtest TM Test Strips.

Source page: https://510kreport.com/device/K091460
Methodology: https://510kreport.com/methodology