510(k) · Cleared
ClearedUniCel DxC SYNCHRON System HDL Cholesterol reagent (HDL),Unicel DxC SYNCHRON System HDL Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JIT Calibrator, Secondary
Cleared on Feb 26, 2015 after a 133-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 26, 2015
- Review
- 133 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 JIT? 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?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Reagent: UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL), when used in conjunction with UniCel DxC 600/800 SYNCHRON System(s) and UniCel DxC SYNCHRON Systems HDL Calibrator, is intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and…
Read the full statement (117 words)
Reagent: UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL), when used in conjunction with UniCel DxC 600/800 SYNCHRON System(s) and UniCel DxC SYNCHRON Systems HDL Calibrator, is intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Calibrator: The UniCel DxC SYNCHRON Systems HDL Calibrator is designed to provide suitable calibration levels for Beckman Coulter UniCel DxC 600/800 SYNCHRON Systems employing the quantitative UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K142985 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142985: UniCel DxC SYNCHRON System HDL Cholesterol reagent (HDL),Unicel DxC SYNCHRON System HDL Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142985
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)
- Page last updated Nov 3, 2026