# K113764: Glucose Meter-Check Solution for Infopia

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Jan 30, 2012 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: 3 generations back to K950727 (1995). 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)
- K072369: Evolution Blood Glucose Monitoring System, Hmd Biomedical, LLC (2008) Summary page 3.

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

Source page: https://510kreport.com/device/K113764
Methodology: https://510kreport.com/methodology