# K123966: Glucose Meter-Check Solution for Bayer

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Jan 25, 2013 after 30 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: 9 generations back to K945887 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082395: Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002, Bionostics, Inc. (2008) Summary page 1.

## Indications for use
Glucose Meter-Check Solution Bayer is intended to assess the performance of the following Bayer blood glucose test systems: Bayer Contour Next blood glucose monitoring systems *Bayer Breeze 2 blood glucose monitoring systems *Bayer Contour and Contour TS blood glucose monitoring systems Glucose Meter-Check Solution for Bayer is intended for use by healthcare professionals and people with diabetes mellitus at home.

Source page: https://510kreport.com/device/K123966
Methodology: https://510kreport.com/methodology