510(k) · Cleared
ClearedLiquid N-Geneous HDL Cholesterol Kit/Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Corp. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on Jun 16, 1997 after a 77-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jun 16, 1997
- Review
- 77 days
- Class
- Class I
- Product code
- LBS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK971162 Liquid N-Geneous HDL Cholesterol Kit/CalibratorGenzyme Corp. · 1997
- Descendant · cites it directly · 4 of its ownK063841 NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 2008
- Descendant · 2 generations on · 2 of its ownK111516 NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK113830 Vantera Clinical AnalyzerLiposcience · 2012
- Descendant · 2 generations on · 0 of its ownK210801 AXINON® LDL-p Test SystemNumares AG · 2023
- Descendant · 4 generations on · 0 of its ownK133849 Vantera Clinical AnalyzerLiposcience · 2014
Most influential descendants
Showing 5 of 5 · See all- K063841NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 2008 · cites it directly4descendants
- K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011 · 2 generations on2descendants
- K113830Vantera Clinical AnalyzerLiposcience · 2012 · 3 generations on1descendant
- K210801AXINON® LDL-p Test SystemNumares AG · 2023 · 2 generations on0descendants
- K133849Vantera Clinical AnalyzerLiposcience · 2014 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971162 | Liquid N-Geneous HDL Cholesterol Kit/Calibrator | Genzyme Corp. | 1997 | — |
| +1 | K063841 | NMR Profiler and NMR Lipoprofile Assay, Controls | Liposcience | 2008 | — |
| +2 | K111516 | NMR Lipoprofile (R) Test and NMR Profiler | Liposcience, Inc. | 2011 | — |
| +3 | K113830 | Vantera Clinical Analyzer | Liposcience | 2012 | — |
| +2 | K210801 | AXINON® LDL-p Test System | Numares AG | 2023 | — |
| +4 | K133849 | Vantera Clinical Analyzer | Liposcience | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 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 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? (2)
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 |
|---|---|---|---|
| * | — | Sodium Phosphotungstate MgCl₂ (PTA) method Named without a submission number | |
| * | — | CDC Designated Comparison Method Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063841 | NMR Profiler and NMR Lipoprofile Assay, Controls | 2008 | 4 |
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, K063841 (Liposcience, 2008) has gone furthest, with 4 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?
For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in human serum and plasma.
For the calibration of the Liquid N-geneous HDL Cholesterol assay.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971162 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971162: Liquid N-Geneous HDL Cholesterol Kit/Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971162
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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