510(k) · Cleared
ClearedRna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4
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 Jul 12, 2002 as substantially equivalent to K012430 (Bionostics, Inc., 2001) and 1 other predicate after a 57-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Jul 12, 2002
- Review
- 57 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K925479 (1993). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK925479 Sugar Chex Linearity for the One TouchStreck Laboratories, Inc. · 1993
- 1 generation backK012430 Multi-Meter Glucose Calibration Verification Material, Model Rna GL3Bionostics, Inc. · 2001
- This deviceK021624 Rna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4Bionostics, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK081478 Rna Medical Glucose and B-Ketone Calibration Verification ControlsBionostics, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K081478Rna Medical Glucose and B-Ketone Calibration Verification ControlsBionostics, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925479 | Sugar Chex Linearity for the One Touch | Streck Laboratories, Inc. | 1993 | — |
| −1 | K012430 | Multi-Meter Glucose Calibration Verification Material, Model Rna GL3 | Bionostics, Inc. | 2001 | — |
| 0 (this device) | K021624 | Rna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4 | Bionostics, Inc. | 2002 | — |
| +1 | K081478 | Rna Medical Glucose and B-Ketone Calibration Verification Controls | Bionostics, Inc. | 2008 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K012430 | Multi-Meter Glucose Calibration Verification Material, Model Rna GL3Summary page 1…GM Calibration Verification Material Control 510(k), Date: K012430,0%127101 K002540,09/18/00 Number of 5* 5 5… | 2001 |
| * | K002540 | Bionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test…Summary page 1…Verification Material Control 510(k), Date: K012430,0%127101 K002540,09/18/00 Number of 5* 5 5* levels:… | 2000 |
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 |
|---|---|---|---|
| K081478 | Rna Medical Glucose and B-Ketone Calibration Verification Controls | 2008 | 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 9 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K081478 (Bionostics, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K012430.
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?
RNA GL4 Glucose Calibration Verification Control 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 as stated in the FDA summary.
https://510kreport.com/device/K021624 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021624: Rna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021624
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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