# K210801: AXINON® LDL-p Test System

- Pathway: 510(k) (Traditional)
- Applicant: Numares AG
- Decided: Jul 19, 2023 after 854 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: 3 generations back to K971573 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 4.

## Indications for use
The AXINON® LDL-p Test System is intended to measure lipoprotein particles to quantify LDL particle number (LDL-p) using nuclear magnetic resonance (NMR) spectroscopy that measures the 600 MHz proton nuclear magnetic resonance (NMR) spectrum of a human serum sample. LDL-p concentration values 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 system is for professional use only.

Source page: https://510kreport.com/device/K210801
Methodology: https://510kreport.com/methodology