# K112356: Glucose Meter-Check Control Solution for Agamatrix Wavesense

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Sep 19, 2011 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K052762 (2006). 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)
- K052762: Liberty Blood Glucose Monitoring System, Model 8000-0067, Agamatrix, Inc. (2006) Summary page 1.

## Indications for use
The Glucose Meter-Check Control Solution for AgaMatrix is intended for use to verify the performance and correct operation of the AgaMatrix blood glucose monitoring test systems utilizing the WaveSense family of blood glucose test strips. Glucose Meter-Check Control Solution for AgaMatrix is intended for use by healthcare professionals and people with diabetes mellitus at home.

Source page: https://510kreport.com/device/K112356
Methodology: https://510kreport.com/methodology