510(k) · Cleared
ClearedGlucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Sep 18, 2008 as substantially equivalent to K062347 (Bayer Healthcare, LLC, 2006) and 3 other predicates after a 30-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- Sep 18, 2008
- Review
- 30 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K945887 (1995). 24 ancestors in all, the oldest K850368 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 7 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 6 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 5 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 4 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 3 generations backK052980 Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005
- 2 generations backK060706 Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
- 1 generation backK070506 SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007
- This deviceK082395 Glucose Meter-Check Control Solution for Bayer Ascensia Blood…Bionostics, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK123966 Glucose Meter-Check Solution for BayerBionostics, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K123966Glucose Meter-Check Solution for BayerBionostics, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −7 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −6 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −5 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −4 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −3 | K052980 | Liberty Glucose Control, Model 2120031 | Liberty Healthcare Group, Inc. | 2005 | — |
| −2 | K060706 | Liberty Normal Glucose Control Solution | Liberty Healthcare Group, Inc. | 2006 | — |
| −1 | K070506 | SMS Multi Glucose Control, Model 2120049 | Medical Specialties Supply Co., Inc. | 2007 | — |
| 0 (this device) | K082395 | Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter… | Bionostics, Inc. | 2008 | — |
| +1 | K123966 | Glucose Meter-Check Solution for Bayer | Bionostics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062347 | Ascensia Breeze 2 Blood Glucose Monitoring SystemSummary page 1…Contour Elite DEX 2 Control Solution 510(k), Date K062347 K023657 K043311 K023584 K070506 11… | 2006 |
| 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…Elite DEX 2 Control Solution 510(k), Date K062347 K023657 K043311 K023584 K070506 11-21-06 05… | |
| * | K043311 | Ascensia Elite Diabetes Care SystemSummary page 1…DEX 2 Control Solution 510(k), Date K062347 K023657 K043311 K023584 K070506 11-21-06 05-11-04 12… | 2004 |
| * | K023584 | Ascensia Dex 2 Diabetes Care SystemSummary page 1…Control Solution 510(k), Date K062347 K023657 K043311 K023584 K070506 11-21-06 05-11-04 12-22-04 11… | 2002 |
| * | K070506 | SMS Multi Glucose Control, Model 2120049Summary page 1…Solution 510(k), Date K062347 K023657 K043311 K023584 K070506 11-21-06 05-11-04 12-22-04 11-20-02 04… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123966 | Glucose Meter-Check Solution for Bayer | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K123966 (Bionostics, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062347.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082395: Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082395
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026