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.
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Microbiology
The Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets from Clinical Specimens in Near-Patient Settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens, designed for simple use by healthcare professionals in near-patient settings outside centralized laboratories, without requiring sample manipulation, transport to a specialized area, or complex analyte measurements. It aids in the diagnosis of COVID-19 infections. Classified as FDA Class 2 under regulation 866.3982, it requires 510(k) clearance in the Microbiology specialty. It is not an implant and not life-sustaining.
510(k) Clearances
7 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.