510(k) · Cleared
ClearedBionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood Glucose Monitoring System
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 Feb 28, 2000 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Feb 28, 2000
- Review
- 27 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK000318 Bionostics Glucose Quality Control Solution for Use with the…Bionostics, Inc. · 2000
- Descendant · cites it directly · 9 of its ownK022769 Lifescan Onetouch Ultra Control SolutionBionostics, Inc. · 2002
- Descendant · 2 generations on · 4 of its ownK160179 VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK173140 VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino…Vivachek Laboratories, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK111456 Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 2012
- Descendant · 4 generations on · 1 of its ownK233058 VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K022769Lifescan Onetouch Ultra Control SolutionBionostics, Inc. · 2002 · cites it directly9descendants
- K160179VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc. · 2017 · 2 generations on4descendants
- K173140VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose…Vivachek Laboratories, Inc. · 2018 · 3 generations on3descendants
- K111456Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 2012 · 2 generations on2descendants
- K233058VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000318 | Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact… | Bionostics, Inc. | 2000 | — |
| +1 | K022769 | Lifescan Onetouch Ultra Control Solution | Bionostics, Inc. | 2002 | — |
| +2 | K160179 | VivaChek Ino Blood Glucose Monitoring System | Vivachek Laboratories, Inc. | 2017 | — |
| +3 | K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood… | Vivachek Laboratories, Inc. | 2018 | — |
| +2 | K111456 | Medisign Blood Glucose Monitoring System | Tianjin Empecs Medical Device Co., Ltd. | 2012 | — |
| +4 | K233058 | VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (11)
See all 112 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, K022769 (Bionostics, Inc., 2002) has gone furthest, with 9 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/K000318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000318: Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000318
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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