# K081403: Glucose Meter-Check Control Solution for Roche Accu-Chek

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Jul 25, 2008 after 67 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: 8 generations back to K945887 (1995). 34 ancestors in all.
2 later devices descend 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)
- K043474: Accu-Chek Aviva System, Roche Diagnostics Corp. (2005) Summary page 1.
- K012324: Accu-Chek Active Test System, Roche Diagnostics Corp. (2001) Summary page 1.
- K032552: Accu-Chek Advantage System, Roche Diagnostics Corp. (2003) Summary page 1.
- K022171: Accu-Chek Compact System, Roche Diagnostics Corp. (2002) Summary page 1.
- K070506: SMS Multi Glucose Control, Model 2120049, Medical Specialties Supply Co., Inc. (2007) Summary page 1.

## Most influential descendants
- K123851: Glucose Meter-Check Solution for Roche Accu-Chek (2013), 1 descendant of its own
- K152493: POGO Automatic Blood Glucose Monitoring System (2016), 0 descendants of its own

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

Source page: https://510kreport.com/device/K081403
Methodology: https://510kreport.com/methodology