# K090854: Abt Glucose Control Solution, Model 2120090

- Pathway: 510(k) (Traditional)
- Applicant: American Biological Technologies, Inc.
- Decided: Apr 16, 2009 after 17 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: 8 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)
- K081915: FDTX Glucose Control Solution, Fujirebio Diagnostics Texas, Inc. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K023657: Contour TS Control Solution Normal. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree 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 Contour TS Blood Glucose Monitor.

Source page: https://510kreport.com/device/K090854
Methodology: https://510kreport.com/methodology