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, Met
Hematology
The MET antibody immunohistochemistry assay is a qualitative immunohistochemical antibody intended to detect MET protein expression in human clinical tissue specimens, functioning as a companion diagnostic to aid in identifying patients eligible for treatment with specific FDA-approved therapeutic drugs targeting the MET pathway. It is classified as FDA Class III (PMA required) under regulation 864.1860 in the Hematology specialty, reviewed by the Pathology panel, with product code SER. Class III classification reflects the high-stakes nature of companion diagnostics; the device is not an implant and does not support life-sustaining functions.
No 510(k) clearances found for "SER". 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.