510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Immunology
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.
510(k) Clearances
8 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.