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.
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Microbiology
An enzyme-linked immunosorbent assay (ELISA) for rotavirus is a laboratory diagnostic test used to detect rotavirus antigens or antibodies in patient stool or serum specimens, supporting the diagnosis of rotavirus gastroenteritis, particularly in young children and immunocompromised patients. The device is FDA Class 1, the lowest risk category, requiring only general controls and exempt from premarket notification. It carries product code LIQ and is regulated under 21 CFR 866.3405 within the Microbiology specialty. No special flags apply to this device.
510(k) Clearances
33 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.