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.
Assay, Genotyping, Hepatitis C Virus
Microbiology
The Hepatitis C Virus Genotyping Assay (product code OBF) is an in vitro diagnostic device used for the qualitative detection and classification of eight clinically relevant Hepatitis C Virus (HCV) RNA genotypes in patient specimens. Knowing the HCV genotype is clinically important because it guides treatment selection and duration for antiviral therapy. This device is regulated under FDA Class 2, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device, and is subject to general and special controls. It falls under regulation 866.3170 in the Microbiology specialty and carries no implant or life-sustaining flags.
No 510(k) clearances found for "OBF". Try a different K-number, product code, or device name.
What 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.