Product code NOE

Device name: Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Medical specialty: Immunology
Device class: 2
Regulation number: 866.5600
Review panel: IM
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
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.
Source: FDA openFDA device classification dataset

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

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00817089023222	Diazyme	DIAZYME LABORATORIES, INC.	2026-01-21
00817089023239	Diazyme	DIAZYME LABORATORIES, INC.	2026-01-21
00817089021433	Diazyme	DIAZYME LABORATORIES, INC.	2020-07-21

Related 510(k) Records#