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.
Immunohistochemistry Assay, Antibody, Folr1
Hematology
The Immunohistochemistry Assay, Antibody, FOLR1 is a qualitative immunohistochemical antibody-based assay intended to identify folate receptor alpha (FOLR1) protein expression in human tissue specimens, functioning as a companion diagnostic to aid in identifying patients with specific cancers who are eligible for treatment with FDA-approved FOLR1-targeted therapeutic drugs. Classified as FDA Class 3 under regulation 864.1860, it requires Premarket Approval (PMA) given its role in directing therapeutic decision-making, reviewed under the Pathology panel with Hematology specialty designation. It is not an implant and not life-sustaining.
No 510(k) clearances found for "QUL". Try a different K-number, product code, or device name.
What 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.