FDA Product Code NOE: Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2
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.
Leading manufacturers include Diazyme Laboratories, Inc..
FDA 510(k) Cleared Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 Devices (Product Code NOE)
About Product Code NOE - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code NOE since 2003, with 8 receiving FDA clearance (average review time: 134 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
NOE devices are reviewed by the Chemistry panel. Browse all Chemistry devices →