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 Diadexus, Inc. and Diazyme Laboratories, Inc..
8
Total
8
Cleared
134d
Avg days
2003
Since
FDA 510(k) Cleared Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 Devices (Product Code NOE)
8 devices
Cleared
Aug 06, 2021
Diazyme PLAC® Test for Lp-PLA2 Activity
Diazyme Laboratories, Inc.
Chemistry
290d
Cleared
Dec 15, 2014
PLAC TEST FOR LP-PLA2 ACTIVITY
Diadexus, Inc.
Chemistry
186d
Cleared
Jan 03, 2011
PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115
Diadexus, Inc.
Chemistry
186d
Cleared
Dec 20, 2007
PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109
Diadexus, Inc.
Chemistry
97d
Cleared
Sep 11, 2006
MODIFICATION TO DIADEXUS PLAC TEST
Diadexus, Inc.
Chemistry
40d
Cleared
Jun 15, 2005
DIADEXUS PLAC TEST
Diadexus, Inc.
Chemistry
105d