Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
The lipoprotein-associated phospholipase A2 (Lp-PLA2) immunoassay test system is an in vitro diagnostic device intended to measure Lp-PLA2 levels in human plasma as an aid in predicting the risk of coronary heart disease when used alongside clinical evaluation and other risk factors. This marker differs from traditional lipoprotein assays in that it measures an enzyme produced by macrophages, representing a novel cardiovascular risk biomarker. It is classified as FDA Class 2 under regulation 866.5600 in the Immunology specialty, requiring 510(k) clearance. Product code NOE is eligible for third-party review.
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Basic Information
- Product Code
- NOE
- Device Class
- FDA class 2
- Regulation Number
- 866.5600
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | Aug 06, 2021 | Substantially Equivalent | Diazyme Laboratories, Inc. |
| K141575 | PLAC TEST FOR LP-PLA2 ACTIVITY | Dec 15, 2014 | Substantially Equivalent | Diadexus, Inc. |
| K101853 | PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 | Jan 03, 2011 | Substantially Equivalent | Diadexus, Inc. |
| K072599 | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 | Dec 20, 2007 | Substantially Equivalent | Diadexus, Inc. |
| K062234 | MODIFICATION TO DIADEXUS PLAC TEST | Sep 11, 2006 | Substantially Equivalent | Diadexus, Inc. |
| K050523 | DIADEXUS PLAC TEST | Jun 15, 2005 | Substantially Equivalent | Diadexus, Inc. |
| K040101 | MODIFICATION TO DIADEXUS PLAC TEST | Feb 05, 2004 | Substantially Equivalent | Diadexus, Inc. |
| K030477 | DIADEXUS PLAC TEST | Jul 18, 2003 | Substantially Equivalent | Diadexus, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.