510(k) · Cleared
ClearedNMR Lipoprofile (R) Test and NMR Profiler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liposcience, Inc. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on Sep 27, 2011 as substantially equivalent to K063841 (Liposcience, 2008) after a 118-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.
- Decided
- Sep 27, 2011
- Review
- 118 days
- Class
- Class I
- Product code
- LBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971573 (1997). 5 ancestors in all, the oldest K971162 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK971573 N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol…Genzyme Corp. · 1997
- 2 generations backK020724 Dimension Automated LDL Cholesterol Flex Reagentcartridge Method…Dade Behring, Inc. · 2002
- 1 generation backK063841 NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 2008
- This deviceK111516 NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK113830 Vantera Clinical AnalyzerLiposcience · 2012
- Descendant · 2 generations on · 0 of its ownK133849 Vantera Clinical AnalyzerLiposcience · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971573 | N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator… | Genzyme Corp. | 1997 | — |
| −2 | K020724 | Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131 | Dade Behring, Inc. | 2002 | — |
| −1 | K063841 | NMR Profiler and NMR Lipoprofile Assay, Controls | Liposcience | 2008 | — |
| 0 (this device) | K111516 | NMR Lipoprofile (R) Test and NMR Profiler | Liposcience, Inc. | 2011 | — |
| +1 | K113830 | Vantera Clinical Analyzer | Liposcience | 2012 | — |
| +2 | K133849 | Vantera Clinical Analyzer | Liposcience | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K063841 | NMR Profiler and NMR Lipoprofile Assay, ControlsSummary page 1…e JIT Panel: Clinical Chemistry (75) D. Legally Marketed Device to which Equivalence is Claimed (Predicate Device): NMR Profiler and NMR Lipoprofile Assay, K063841 LipoScience, Inc CONFIDENTIAL Page 5.1 Prernarket Notificati… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113830 | Vantera Clinical Analyzer | 2012 | 1 |
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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K113830 (Liposcience, 2012) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K063841.
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. 2011, 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?
The NMR LipoProfile®test, when used with the NMR Profiler, an automated NMR spectrometer, measures lipoprotein particles to quantify LDL particle number (LDL-P), HDL cholesterol (HDL-C), and triglycerides in human serum and plasma using nuclear magnetic resonance (NMR) spectroscopy. LDL-P and these NMR-derived concentrations of HDL-C and triglycerides are used in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease. This test is performed and provided as a service by LipoScience Laboratory.
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/K111516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111516: NMR Lipoprofile (R) Test and NMR Profiler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111516
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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