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.
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Microbiology
The FISH (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, RNA, Staphylococcus Aureus (product code NXX) is a qualitative nucleic acid hybridization assay used for the presumptive identification of Staphylococcus aureus from blood cultures with gram-positive cocci in clusters. It is classified as FDA Class 1, regulated under 21 CFR 866.3700 within the Microbiology specialty, and is not exempt from 510(k) requirements per 21 CFR part 866.9(c)(6). The device carries no implant or life-sustaining flags.
510(k) Clearances
4 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.