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.
Levetiracetam Assay
Clinical Toxicology
The Levetiracetam Assay (product code ORI) is an in vitro diagnostic test for the quantitative determination of levetiracetam concentrations in human serum or plasma. Levetiracetam is an antiepileptic medication, and this assay supports therapeutic drug monitoring to aid in patient management. As an FDA Class 2 device under regulation 862.3350, it requires 510(k) premarket clearance and falls within the Clinical Toxicology specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.
510(k) Clearances
2 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.