510(k) · Cleared
ClearedBionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test Strip Systems
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, 2000 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Sep 18, 2000
- Review
- 33 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK002540 Bionostics Glucose Quality Control Solution for Use with Medisense…Bionostics, Inc. · 2000
- Descendant · cites it directly · 5 of its ownK012430 Multi-Meter Glucose Calibration Verification Material, Model Rna GL3Bionostics, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK021624 Rna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4Bionostics, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK081478 Rna Medical Glucose and B-Ketone Calibration Verification ControlsBionostics, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK032819 Glucose Control Solution for Chdiagnostics Senova, Chdignostics…Bionostics, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK021697 Glucose Control Solution for BD LatitudeBionostics, Inc. · 2002
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K012430Multi-Meter Glucose Calibration Verification Material, Model Rna GL3Bionostics, Inc. · 2001 · cites it directly5descendants
- K021624Rna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4Bionostics, Inc. · 2002 · cites it directly1descendant
- K081478Rna Medical Glucose and B-Ketone Calibration Verification ControlsBionostics, Inc. · 2008 · 2 generations on0descendants
- K032819Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose…Bionostics, Inc. · 2003 · 2 generations on0descendants
- K021697Glucose Control Solution for BD LatitudeBionostics, Inc. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002540 | Bionostics Glucose Quality Control Solution for Use with Medisense Blood… | Bionostics, Inc. | 2000 | — |
| +1 | K012430 | Multi-Meter Glucose Calibration Verification Material, Model Rna GL3 | Bionostics, Inc. | 2001 | — |
| +1 | K021624 | Rna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4 | Bionostics, Inc. | 2002 | — |
| +2 | K081478 | Rna Medical Glucose and B-Ketone Calibration Verification Controls | Bionostics, Inc. | 2008 | — |
| +2 | K032819 | Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood… | Bionostics, Inc. | 2003 | — |
| +2 | K021697 | Glucose Control Solution for BD Latitude | Bionostics, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K012430 (Bionostics, Inc., 2001) has gone furthest, with 5 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K002540 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002540: Bionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test Strip Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002540
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026