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.
Sars-Cov-2 Serology Test
Microbiology
The SARS-CoV-2 Serology Test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens, intended to aid in identifying individuals who have mounted an adaptive immune response to the virus, such as following infection or vaccination. It is not intended for diagnosing acute SARS-CoV-2 infection or for screening blood and tissue donors. Classified as FDA Class 2 under regulation 866.3983, it requires 510(k) clearance in the Microbiology specialty. It is not an implant and not life-sustaining.
510(k) Clearances
5 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.