# K113830: Vantera Clinical Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Liposcience
- Decided: Aug 30, 2012 after 247 days
- Product code: CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides)
- Device class: 1
- Regulation: 21 CFR 862.1705
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K971573 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites 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)
- K111516: NMR Lipoprofile (R) Test and NMR Profiler, Liposcience, Inc. (2011) Summary page 1.
- K073506: Luminex LX 100/200 Instrument, Luminex Corp. (2008) Summary page 1.

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

## Indications for use
The Vantera® Clinical Analyzer is an automated laboratory test analyzer which measures the 400 MHz proton nuclear magnetic resonance (NMR) spectrum of clinical samples to produce signal amplitudes, converting these signal amplitudes to analyte concentration. The device includes a 400 MHz NMR spectrometer and software to analyze digitized spectral data. This instrumentation is intended to be used with NMR based assays to detect multiple analytes from clinical samples. The NMR LipoProfile test, when used with the Vantera® Clinical Analyzer, 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.

Source page: https://510kreport.com/device/K113830
Methodology: https://510kreport.com/methodology