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.
Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma
Immunology
The Soluble Mesothelin-Related Peptides Cancer Monitoring Test System for Mesothelioma is a diagnostic device used to monitor mesothelioma cancer patients after therapy for disease progression, used in conjunction with other diagnostic modalities. Mesothelin-related peptides in serum or plasma serve as biomarkers for monitoring treatment response in mesothelioma. It is an FDA Class 2 device regulated under 21 CFR 866.6010 in the Immunology specialty, with product code NVA, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.
No 510(k) clearances found for "NVA". 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.