510(k) · Cleared
ClearedNMR Profiler and NMR Lipoprofile Assay, Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liposcience · MRR System, Test, Low Density, Lipoprotein
Cleared on Jul 23, 2008 as substantially equivalent to K020724 (Dade Behring, Inc., 2002) and 2 other predicates after a 575-day review. Its family tree reaches back 2 generations to 1997. 4 later devices descend from it.
- Decided
- Jul 23, 2008
- Review
- 575 days
- Class
- Class I
- Product code
- MRR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K971573 (1997). 4 ancestors in all, the oldest K971162 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971573 N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol…Genzyme Corp. · 1997
- 1 generation backK020724 Dimension Automated LDL Cholesterol Flex Reagentcartridge Method…Dade Behring, Inc. · 2002
- This deviceK063841 NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience · 2008
- Descendant · cites it directly · 2 of its ownK111516 NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK113830 Vantera Clinical AnalyzerLiposcience · 2012
- Descendant · cites it directly · 0 of its ownK210801 AXINON® LDL-p Test SystemNumares AG · 2023
- Descendant · 3 generations on · 0 of its ownK133849 Vantera Clinical AnalyzerLiposcience · 2014
Most influential descendants
Showing 4 of 4 · See all- K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc. · 2011 · cites it directly2descendants
- K113830Vantera Clinical AnalyzerLiposcience · 2012 · 2 generations on1descendant
- K210801AXINON® LDL-p Test SystemNumares AG · 2023 · cites it directly0descendants
- K133849Vantera Clinical AnalyzerLiposcience · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971573 | N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator… | Genzyme Corp. | 1997 | — |
| −1 | K020724 | Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131 | Dade Behring, Inc. | 2002 | — |
| 0 (this device) | K063841 | NMR Profiler and NMR Lipoprofile Assay, Controls | Liposcience | 2008 | — |
| +1 | K111516 | NMR Lipoprofile (R) Test and NMR Profiler | Liposcience, Inc. | 2011 | — |
| +2 | K113830 | Vantera Clinical Analyzer | Liposcience | 2012 | — |
| +1 | K210801 | AXINON® LDL-p Test System | Numares AG | 2023 | — |
| +3 | 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 |
|---|---|---|
| 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 MRR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRR device
- #1 K241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica®…score 8.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K020724 | Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131Summary page 2…CFR 862.1150, JIT) Predicate Device(s) Device Name: Dimension Automated LDL Cholesterol Flex Reagent Manufacturer: Dade Behring, Inc. 510(k) Number: K020724 Device Name: Triglycerides Reagent Manufacturer: Carolina Liquid Chemistries 510(k) Number. K971324… | 2002 |
| * | K971324 | Triglycerides, TG, or TrigSummary page 2…turer: Dade Behring, Inc. 510(k) Number: K020724 Device Name: Triglycerides Reagent Manufacturer: Carolina Liquid Chemistries 510(k) Number. K971324 Device Name: Liquid N-geneous HDL Cholesterol Kit Manufacturer: Genzyme Corporation 510(k) Number: K971162… | 1997 |
| * | K971162 | Liquid N-Geneous HDL Cholesterol Kit/CalibratorSummary page 2…Liquid Chemistries 510(k) Number. K971324 Device Name: Liquid N-geneous HDL Cholesterol Kit Manufacturer: Genzyme Corporation 510(k) Number: K971162 Intended Use / Indications for Use The NMR LipoProfile®-2 test, used with the NMR Profiler, an automated NMR spectrometer, meas… | 1997 |
What descends from it? (4)
2 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)
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 11 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K111516 (Liposcience, Inc., 2011) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K020724.
How does its category compare?
All MRR devicesMRR System, Test, Low Density, Lipoprotein: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MRR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MRR
Too few MRR 510(k)s in any year since 2007 to give a median.
Recalls per year · MRR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRR
1in 2024
MAUDE reports naming product code MRR, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 2 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NMR LipoProfile®-2 test, 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 serum and plasma using nuclear magnetic resonance (NMR) spectroscopy. LDL-P and these NMR-derived concentrations of triglycerides and HDL-C are used in conjunction with other lipid measurements and clinical evaluation to aid in the management of lipoprotein disorders associated with cardiovascular disease. The test is performed and provided as a service by Liposcience Laboratory.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063841: NMR Profiler and NMR Lipoprofile Assay, Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063841
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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