# K111516: NMR Lipoprofile (R) Test and NMR Profiler

- Pathway: 510(k) (Traditional)
- Applicant: Liposcience, Inc.
- Decided: Sep 27, 2011 after 118 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
- 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: 3 generations back to K971573 (1997). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063841: NMR Profiler and NMR Lipoprofile Assay, Controls, Liposcience (2008) Summary page 1.

## Most influential descendants
- K113830: Vantera Clinical Analyzer (2012), 1 descendant of its own
- K133849: Vantera Clinical Analyzer (2014), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K111516
Methodology: https://510kreport.com/methodology