# K082395: Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Sep 18, 2008 after 30 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). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062347: Ascensia Breeze 2 Blood Glucose Monitoring System, Bayer Healthcare, LLC (2006) Summary page 1.
- K043311: Ascensia Elite Diabetes Care System, Bayer Healthcare, LLC (2004) Summary page 1.
- K023584: Ascensia Dex 2 Diabetes Care System, Bayer Corp. (2002) Summary page 1.
- K070506: SMS Multi Glucose Control, Model 2120049, Medical Specialties Supply Co., Inc. (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K023657: Ascensia Contour. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K123966: Glucose Meter-Check Solution for Bayer (2013), 0 descendants of its own

## Indications for use
Glucose Meter-Check Control Solution is intended to assess the performance of the following Bayer blood glucose test systems: • Bayer Ascensia Breeze® 2 • Bayer Ascensia Contour® • Bayer Ascensia Elite® • Bayer Ascensia DEX®2 The Meter-Check Glucose Control Solution is intended for use by healthcare professional and people with diabetes mellitus at home.

Source page: https://510kreport.com/device/K082395
Methodology: https://510kreport.com/methodology