# K092645: Fdi Glucose Control Levels 1, 2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Sep 5, 2009 after 9 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 K030703 (2003). 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)
- K030703: Truetrack Smart System Blood Glucose Meter and True Track Smart System Blood Glucose Test Strips, Home Diagnostics, Inc. (2003) 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 TrueTrack®, TrackEASE® and TRUEread T M meters and test strips.

Source page: https://510kreport.com/device/K092645
Methodology: https://510kreport.com/methodology