510(k) · Cleared
ClearedHDL Cholesterol (HDLX) Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on May 14, 2010 as substantially equivalent to K040692 (Olympus America, Inc., 2004) after a 130-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- May 14, 2010
- Review
- 130 days
- Class
- Class I
- Product code
- LBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040692 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK040692 Olympus HDL Cholesterol Reagent, OSR6195/OSR6295 and Olympus HDL…Olympus America, Inc. · 2004
- This deviceK100010 HDL Cholesterol (HDLX) AssayBeckman Coulter, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040692 | Olympus HDL Cholesterol Reagent, OSR6195/OSR6295 and Olympus HDL Cholesterol… | Olympus America, Inc. | 2004 | — |
| 0 (this device) | K100010 | HDL Cholesterol (HDLX) Assay | Beckman Coulter, Inc. | 2010 | — |
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 LBS? 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 |
|---|---|---|---|
| * | K040692 | Olympus HDL Cholesterol Reagent, OSR6195/OSR6295 and Olympus HDL Cholesterol Calibrator…Summary page 3…0.991 100 Olympus HDLX Systems HDL 800 Assay (K040692) Cholesterol (H DLX) ____ SYNCHRON… | 2004 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LBS devicesLBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LBS
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · LBS
118in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBS
6in 2025
MAUDE reports naming product code LBS, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 129 | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 3 | 118 | 0 | 3 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
HDLX reagent, when used in conjunction with SYNCHRON LX®9 System(s), UniCe1® DxC 800 System(s) and Genzyme Liquid N-geneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma
HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100010: HDL Cholesterol (HDLX) Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100010
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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