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.
Parainfluenza Multiplex Nucleic Acid Assay
Microbiology
The Parainfluenza Multiplex Nucleic Acid Assay (product code OOU) is a Class 2 in vitro diagnostic device regulated under 21 CFR 866.3980 in the Microbiology specialty (MI), cleared via 510(k). It is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza virus types 1, 2, 3, and 4 nucleic acids from human respiratory specimens or viral culture, aiding in the diagnosis of respiratory tract parainfluenza infections when used alongside other clinical and laboratory findings. The device is not an implant or 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.