510(k) · Cleared
Recalled · Class II · 2016Direct HDL-Cholestrol Liquid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on Jul 30, 1998 after a 38-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 30, 1998
- Review
- 38 days
- Class
- Class I
- Product code
- LBS
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK982341 Direct HDL-Cholestrol LiquidRandox Laboratories, Ltd. · 1998
- Descendant · cites it directly · 0 of its ownK153435 Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK132031 Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS · 2014
- Descendant · cites it directly · 0 of its ownK031924 Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL…Ortho-Clinical Diagnostics · 2003 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd. · 2016 · cites it directly0descendants
- K132031Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS · 2014 · cites it directly0descendants
- K031924Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL Reagent Pack, Calibrator…Ortho-Clinical Diagnostics · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982341 | Direct HDL-Cholestrol Liquid | Randox Laboratories, Ltd. | 1998 | — |
| +1 | K153435 | Direct HDL Cholesterol (HDL) | Randox Laboratories, Ltd. | 2016 | — |
| +1 | K132031 | Afinion Lipid Panel and Afinion Lipid Panel Control | Axis-Shield Poc AS | 2014 | — |
| +1 | K031924 | Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL Reagent Pack… | Ortho-Clinical Diagnostics | 2003 | 29 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2014 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2016 | Class II | Z-1653-2016 | Device Design | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K153435 (Randox Laboratories, Ltd., 2016) has gone furthest, with 0 descendants of its own.
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.
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?
The Randox Liquid Direct HDL-Cholesterol (HDL-C) test kit is an in vitro diagnostic reagent for the quantitative determination of HDL-Cholesterol in human serum and plasma. Accurate measurement of HDL-C is of importance when assessing patient risk from coronary heart disease.
In this diagnostic test kit a method for direct measurement of HDL-C, without sample pretreatment is presented.
It is recommended that this test kit be used by suitable qualified laboratory personnel under appropriate laboratory conditions.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982341: Direct HDL-Cholestrol Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982341
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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