# K123851: Glucose Meter-Check Solution for Roche Accu-Chek

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Feb 14, 2013 after 62 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). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081403: Glucose Meter-Check Control Solution for Roche Accu-Chek, Bionostics, Inc. (2008) Summary page 2.
- (no number) Roche ACCU-CHEK branded control solution: named in the summary without a submission number

## Most influential descendants
- K152493: POGO Automatic Blood Glucose Monitoring System (2016), 0 descendants of its own

## Indications for use
Glucose Meter-Check Solution Roche ACCU-CHEK is intended to assess the performance of the following Roche ACCU-CHEK blood glucose monitoring systems: *Roche ACCU-CHEK Nano SmartView® using SmartView® test strips *Roche ACCU-CHEK Aviva® and ACCU-CHEK Aviva Combo® using Aviva Plus® test strips *Roche ACCU-CHEK Active® using ACCU-CHEK Active test strips Roche ACCU-CHEK Compact® and ACCU-CHEK Compact Plus® using ACCU-CHEK Compact test strips. *Roche ACCU-CHEK Advantage using Comfort Curve® test strips Glucose Meter-Check Solution for Roche ACCU-CHEK is intended for use by healthcare professionals and people with diabetes mellitus at home.

Source page: https://510kreport.com/device/K123851
Methodology: https://510kreport.com/methodology