# K112352: Glucose Meter-Check Control for Nipro Trueresult

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Dec 23, 2011 after 129 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 K080641 (2008). 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)
- K080641: Trueresult Blood Glucose System E4H01-81, Home Diagnostics, Inc. (2008) Summary page 1.

## Indications for use
Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use to verify the performance and correct operation of the NIPRO TRUEresult Glucose Test Systems. Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use by healthcare professionals and people with diabetes mellitus at home.

Source page: https://510kreport.com/device/K112352
Methodology: https://510kreport.com/methodology