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.
Influenza A Virus Subtype Differentiation Nucleic Acid Assay
Microbiology
The Influenza A Virus Subtype Differentiation Nucleic Acid Assay (product code OEP) is a microbiology in vitro diagnostic device that qualitatively detects and differentiates between Influenza A virus subtypes in human respiratory specimens or viral culture, aiding in clinical diagnosis and providing epidemiological information for influenza surveillance. Subtype identification is important for public health response to novel influenza strains. This device is FDA Class 2 under regulation 866.3980 in the Microbiology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
510(k) Clearances
1 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.