# K081915: FDTX Glucose Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics Texas, Inc.
- Decided: Aug 8, 2008 after 36 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). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060706: Liberty Normal Glucose Control Solution, Liberty Healthcare Group, Inc. (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K023657: Ascensia Microfill Control Solution. 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.

## Most influential descendants
- K090854: Abt Glucose Control Solution, Model 2120090 (2009), 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 Contour Blood Glucose Monitor.

Source page: https://510kreport.com/device/K081915
Methodology: https://510kreport.com/methodology