# K032819: Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose Test System

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Oct 20, 2003 after 40 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: 2 generations back to K925479 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
Glucose Control Solution for Chdiagnostics Senova'" Blood Glucose Monitoring System is intended for use to verify the performance of the Chdiagnostics Senova'" BGM System at 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/K032819
Methodology: https://510kreport.com/methodology