# K131136: Glucose Meter-Check Solution for Taidoc

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: May 31, 2013 after 39 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 K093724 (2010). 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)
- K093724: Fora Control Solution, Taidoc Control Solution, Taidoc Technology Corporation (2010) Summary page 1.

## Indications for use
Glucose Meter-Check Solution for TaiDoc is intended for in vitro diagnostic use (i.e., for external use only) to assess the performance of blood glucose meters and test strips manufactured by TaiDoc Technology Corporation by healthcare professionals and in the home by people with diabetes mellitus. For In Vitro Diagnostic Use

Source page: https://510kreport.com/device/K131136
Methodology: https://510kreport.com/methodology