510(k) · Cleared
ClearedMulti-Meter Glucose Calibration Verification Material, Model Rna GL3
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 Aug 27, 2001 as substantially equivalent to K925479 (Streck Laboratories, Inc., 1993) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 1993. 5 later devices descend from it.
- Decided
- Aug 27, 2001
- Review
- 27 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K925479 (1993). 2 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK925479 Sugar Chex Linearity for the One TouchStreck Laboratories, Inc. · 1993
- This deviceK012430 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 · cites it directly · 0 of its ownK032819 Glucose Control Solution for Chdiagnostics Senova, Chdignostics…Bionostics, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK021697 Glucose Control Solution for BD LatitudeBionostics, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK013147 Glucose Control Solution for Therasense FreestyleBionostics, Inc. · 2001 · Recalled
Most influential descendants
Showing 5 of 5 · See all- 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 · cites it directly0descendants
- K021697Glucose Control Solution for BD LatitudeBionostics, Inc. · 2002 · cites it directly0descendants
- K013147Glucose Control Solution for Therasense FreestyleBionostics, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925479 | Sugar Chex Linearity for the One Touch | Streck Laboratories, Inc. | 1993 | — |
| 0 (this device) | 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 | — |
| +1 | K032819 | Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood… | Bionostics, Inc. | 2003 | — |
| +1 | K021697 | Glucose Control Solution for BD Latitude | Bionostics, Inc. | 2002 | — |
| +1 | K013147 | Glucose Control Solution for Therasense Freestyle | Bionostics, Inc. | 2001 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2008 | 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? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K925479 | Sugar Chex Linearity for the One TouchSummary page 1…ed Device Name: | Sugar Chex Linearity for | Quality Control Solution | Multi-Meter Glucose One Touch for MediSense BGM Calibration Verification Material 510(k), Date: | K925479, 01/29/93 K002540, 09/18/2000 Number of levels: | 5 5 5 Analytes: | Glucose Glucose Glucose Container: | plastic bottle plastic b… | 1993 |
| * | K002540 | Bionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test…Summary page 1…Sugar Chex Linearity for | Quality Control Solution | Multi-Meter Glucose One Touch for MediSense BGM Calibration Verification Material 510(k), Date: | K925479, 01/29/93 K002540, 09/18/2000 Number of levels: | 5 5 5 Analytes: | Glucose Glucose Glucose Container: | plastic bottle plastic bottle plastic bott… | 2000 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021624 | Rna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4 | 2002 | 1 |
| K032819 | Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose… | 2003 | 0 |
| K021697 | Glucose Control Solution for BD Latitude | 2002 | 0 |
| K013147 | Glucose Control Solution for Therasense Freestyle | 2001 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K021624 (Bionostics, Inc., 2002) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
Multi-Meter Glucose Calibration Verification Material assayed controls are intended for use to verify the performance of multiple blood glucose meters as indicated on the package insert at their upper and lower ends of reportable range and at three points within the range. These controls can therefore be used to assess the linearity and calibration of the test system, or to verify the test systems’ performance.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012430 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012430: Multi-Meter Glucose Calibration Verification Material, Model Rna GL3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012430
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026