# K013147: Glucose Control Solution for Therasense Freestyle

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Oct 24, 2001 after 34 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925479 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012430: Multi-Meter Glucose Calibration Verification Material, Model Rna GL3, Bionostics, Inc. (2001) Summary page 1.
- K000318: Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood Glucose Monitoring System, Bionostics, Inc. (2000) Summary page 1.

## Recalls of this device
- Feb 17, 2006 · Not classified · Z-0605-06: The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.

## Indications for use
Glucose Control Solution for TheraSense FreeStyle Blood Glucose Monitoring System is intended for use to verify the performance of the FreeStyle BGM System at multiple glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

Source page: https://510kreport.com/device/K013147
Methodology: https://510kreport.com/methodology