NOE

Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

Product code

NOE

Device name

Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

Device class

Class 2

21 CFR

21 CFR 866.5600

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

8 (all years; only the last 3 years are listed here)

FDA classification definition

The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, is intended to measure lipoprotein-associated phospholipase A2 in human plasma in conjunction with clinical evaluation and other patient risk factors including biochemical analyses as an aid in predicting risk for coronary heat disease. This device differs from the classification regulation in that it is a different analyte, thus a NEW marker for predicting risk of coronary heart disease. This device is measuring an enzyme that is produced by macrophages where as the regulation is for the measurement of a lipoprotein.

Definition text from the FDA device classification database (U.S. federal government work, public domain).