# K133849: Vantera Clinical Analyzer

- Pathway: 510(k) (Special)
- Applicant: Liposcience
- Decided: Oct 22, 2014 after 307 days
- Product code: NSU (Instrumentation For Clinical Multiplex Test Systems)
- Device class: 2
- Regulation: 21 CFR 862.2570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K971573 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113830: Vantera Clinical Analyzer, Liposcience (2012) Summary page 4.

## 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/K133849
Methodology: https://510kreport.com/methodology