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 Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
Microbiology
The simple point-of-care device to detect SARS-CoV-2 nucleic acid targets from clinical specimens in near-patient settings (product code QWR) is a Class 2 in vitro diagnostic device in the Microbiology specialty (regulation 866.3982) designed for direct detection of SARS-CoV-2 and intended as an aid in diagnosing COVID-19 infections. Requiring 510(k) clearance, the device is simple to use without sample manipulation or laboratory transport and is appropriate for healthcare professionals in near-patient settings outside centralized laboratories. It is not an implant and is not life-sustaining.
510(k) Clearances
3 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.