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.
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Microbiology
The 2009 H1N1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification (product code OQW) is an in vitro diagnostic test used to directly detect and differentiate the 2009 H1N1 influenza virus from human respiratory specimens. It aids in the clinical diagnosis of H1N1 influenza infection during public health surveillance and outbreak response. As an FDA Class 2 device under regulation 866.3332, it requires 510(k) premarket clearance and falls within the Microbiology specialty. The device is not an implant and is not life-sustaining.
510(k) Clearances
10 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.