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.
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
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The Fluorescence In Situ Hybridization (FISH) Test for Bladder Cancer Detection and Monitoring is an in vitro diagnostic device that detects chromosomal aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus in urine specimens using FISH technology. It serves as an adjunctive test for the initial diagnosis of transitional cell carcinoma in symptomatic patients and for monitoring tumor recurrence in previously diagnosed bladder cancer patients. As an FDA Class 3 device requiring Premarket Approval (PMA), it carries the highest regulatory standard due to its high-risk diagnostic role. The product code is NSD, reviewed by the Pathology panel. It is not an implant and does not carry a life-sustaining support flag.
No 510(k) clearances found for "NSD". 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.