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.
Antigen, Elisa, Cryptococcus
Microbiology
The Cryptococcus antigen ELISA is a microbiology in vitro diagnostic device used to detect Cryptococcus antigen in patient serum or cerebrospinal fluid, enabling diagnosis of cryptococcal meningitis and disseminated cryptococcosis, particularly in immunocompromised individuals. It is classified as FDA Class II under 21 CFR 866.3165 within the Microbiology specialty, requiring 510(k) premarket clearance. The product code is MDU and the device is not implanted. Full GMP compliance is required.
510(k) Clearances
2 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.