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.
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Immunology
The Automated Scanning Microscope and Image Analysis System for Fluorescence In Situ Hybridization (FISH) Assays is a device used to automate the scanning and interpretation of FISH-stained microscopy slides, supporting cytogenetic and molecular diagnostic testing. It is an FDA Class 2 device regulated under 21 CFR 866.4700 in the Immunology specialty, reviewed by the Pathology panel, with product code NTH, requiring 510(k) clearance. No detailed definition text is provided in the classification record beyond the device name. It is not an implant and does not provide life-sustaining support.
510(k) Clearances
8 matchesWhat 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.