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
Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
Microbiology
A test for detection of microorganisms causing sexually transmitted infections performed by lay users is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral sexually transmitted infection-causing microorganisms in clinical specimens collected in home settings or similar environments, intended for prescription or over-the-counter use. It is classified as FDA Class II (510(k) required) under regulation 866.3386 in the Microbiology specialty, with product code SEA. The device is not an implant and does not support life-sustaining functions.
510(k) Clearances
1 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.