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.
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Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Test, Factor V Leiden Mutations, Genomic Dna Pcr
Hematology
The Factor V Leiden mutation genomic DNA PCR test is a hematology in vitro diagnostic device used to detect the Factor V Leiden mutation in genomic DNA, aiding in the evaluation of patients with suspected thrombophilia and increased risk of abnormal blood clotting. It is classified as FDA Class 2 under regulation 864.7280 in the Hematology specialty (reviewed by Pathology panel), requiring 510(k) clearance. Product code NPQ is not eligible for third-party review.
510(k) Clearances
6 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.