Product code NOE— Immunology

“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.”

FDA has cleared 8 devices under product code NOE between 2003 and 2021, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20211 clearance
• 20141 clearance
• 20111 clearance
• 20071 clearance
• 20061 clearance
• 20051 clearance
• 20041 clearance
• 20031 clearance

• Diadexus, Inc.7 clearances
• Diazyme Laboratories, Inc.1 clearance

• K203136 — Diazyme PLAC® Test for Lp-PLA2 ActivityDiazyme Laboratories, Inc.·2021-08-06
• K141575 — PLAC TEST FOR LP-PLA2 ACTIVITYDiadexus, Inc.·2014-12-15
• K101853 — PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115Diadexus, Inc.·2011-01-03
• K072599 — PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109Diadexus, Inc.·2007-12-20
• K062234 — MODIFICATION TO DIADEXUS PLAC TESTDiadexus, Inc.·2006-09-11
• K050523 — DIADEXUS PLAC TESTDiadexus, Inc.·2005-06-15
• K040101 — MODIFICATION TO DIADEXUS PLAC TESTDiadexus, Inc.·2004-02-05
• K030477 — DIADEXUS PLAC TESTDiadexus, Inc.·2003-07-18