# K002540: Bionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test Strip Systems

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Sep 18, 2000 after 33 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012430: Multi-Meter Glucose Calibration Verification Material, Model Rna GL3 (2001), 5 descendants of its own
- K021624: Rna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4 (2002), 1 descendant of its own
- K081478: Rna Medical Glucose and B-Ketone Calibration Verification Controls (2008), 0 descendants of its own
- K032819: Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose Test System (2003), 0 descendants of its own
- K021697: Glucose Control Solution for BD Latitude (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K002540
Methodology: https://510kreport.com/methodology