# K063841: NMR Profiler and NMR Lipoprofile Assay, Controls

- Pathway: 510(k) (Traditional)
- Applicant: Liposcience
- Decided: Jul 23, 2008 after 575 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971573 (1997). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020724: Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131, Dade Behring, Inc. (2002) Summary page 2.
- K971324: Triglycerides, TG, or Trig, Carolina Liquid Chemistries Corp. (1997) Summary page 2.
- K971162: Liquid N-Geneous HDL Cholesterol Kit/Calibrator, Genzyme Corp. (1997) Summary page 2.

## Most influential descendants
- K111516: NMR Lipoprofile (R) Test and NMR Profiler (2011), 2 descendants of its own
- K113830: Vantera Clinical Analyzer (2012), 1 descendant of its own
- K210801: AXINON® LDL-p Test System (2023), 0 descendants of its own
- K133849: Vantera Clinical Analyzer (2014), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K063841
Methodology: https://510kreport.com/methodology