510(k) · Cleared
ClearedLinical Enzyme Calibration Verifiers Levels a-E for Beckman Coulter Synchron Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cliniqa Corporation · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Mar 29, 2004 after a 27-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Mar 29, 2004
- Review
- 27 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK040535 Linical Enzyme Calibration Verifiers Levels a-E for Beckman Coulter…Cliniqa Corporation · 2004
- Descendant · cites it directly · 2 of its ownK052010 HBA1C Linearity SetCone Bioproducts · 2005
- Descendant · 2 generations on · 1 of its ownK121534 Cone-Trol Hemoglobin A1C Control SetCone Bioproducts · 2012
- Descendant · 3 generations on · 0 of its ownK162514 Multichem A1cTechnopath Manufacturing · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040535 | Linical Enzyme Calibration Verifiers Levels a-E for Beckman Coulter Synchron… | Cliniqa Corporation | 2004 | — |
| +1 | K052010 | HBA1C Linearity Set | Cone Bioproducts | 2005 | — |
| +2 | K121534 | Cone-Trol Hemoglobin A1C Control Set | Cone Bioproducts | 2012 | — |
| +3 | K162514 | Multichem A1c | Technopath Manufacturing | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJY? 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052010 | HBA1C Linearity Set | 2005 | 2 |
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, K052010 (Cone Bioproducts, 2005) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
CLINIQA LiniCAL TM Enzyme Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Beckman Coulter Synchron® System for Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase, Cholinesterase, Creatine Kinase, Creatine Kinase MB, Lactate Dehydrogenase, Lipase, Gamma Glutamyl Tranferase, and Pancreatic Amylase at five useful concentrations.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040535: Linical Enzyme Calibration Verifiers Levels a-E for Beckman Coulter Synchron Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040535
Report an extraction error
Are you the manufacturer?
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