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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
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The Multi-Analyte Test System with Algorithmic Analysis for Detection of Prostate Cancer is an in vitro diagnostic test system that combines values from multiple assays, with or without additional patient information, to yield a score aiding in the detection of prostate cancer or guiding decisions regarding prostate biopsy. It requires PMA approval as an FDA Class 3 device, reflecting the high risk associated with cancer diagnostic decisions. There is no assigned regulation number, and it is reviewed under the Immunology panel. The device is not an implant and not life-sustaining.
No 510(k) clearances found for "QRF". 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.