510(k) · Cleared
ClearedCone-Trol Hemoglobin A1C Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cone Bioproducts · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Jun 20, 2012 as substantially equivalent to K052010 (Cone Bioproducts, 2005) after a 27-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Jun 20, 2012
- Review
- 27 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040535 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK040535 Linical Enzyme Calibration Verifiers Levels a-E for Beckman Coulter…Cliniqa Corporation · 2004
- 1 generation backK052010 HBA1C Linearity SetCone Bioproducts · 2005
- This deviceK121534 Cone-Trol Hemoglobin A1C Control SetCone Bioproducts · 2012
- Descendant · cites it directly · 0 of its ownK162514 Multichem A1cTechnopath Manufacturing · 2016
Most influential descendants
Showing 1 of 1 · See all- K162514Multichem A1cTechnopath Manufacturing · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040535 | Linical Enzyme Calibration Verifiers Levels a-E for Beckman Coulter Synchron… | Cliniqa Corporation | 2004 | — |
| −1 | K052010 | HBA1C Linearity Set | Cone Bioproducts | 2005 | — |
| 0 (this device) | K121534 | Cone-Trol Hemoglobin A1C Control Set | Cone Bioproducts | 2012 | — |
| +1 | K162514 | Multichem A1c | Technopath Manufacturing | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (1)
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 |
|---|---|---|---|
| * | K052010 | HBA1C Linearity SetSummary page 1…Regulatory Class: Class I Predicate Devices: The CONE-TROL Hemoglobin A ic Control Set is substantially equivalent to Cone Bioproducts' HbAlc Linearity Set (k052010) for its stated intended use. Device Description: The CONE-TROL Hemoglobin Aic Control Set is prepared from huma… | 2005 |
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 |
|---|---|---|---|
| K162514 | Multichem A1c | 2016 | 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 8 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162514 (Technopath Manufacturing, 2016) has gone furthest, with 0 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. 2012, 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?
CONE-TROL Hemoglobin Aic Control Set is intended for use as quality control material
to monitor the performance and precision of Hemoglobin Aic determination methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121534: Cone-Trol Hemoglobin A1C Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121534
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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