# K102260: Fdi Glucose Control Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Sep 24, 2010 after 45 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). 29 ancestors in all.
1 later device descends 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)
- K083549: Abt Glucose Control Solution, American Biological Technologies, Inc. (2008) Summary page 1.

## Most influential descendants
- 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 Lite Blood Glucose Monitor.

Source page: https://510kreport.com/device/K102260
Methodology: https://510kreport.com/methodology