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.
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Microbiology
The Multi-Target Respiratory Specimen Nucleic Acid Test Including SARS-CoV-2 and Other Microbial Agents is an in vitro diagnostic device intended to detect and identify SARS-CoV-2 and other microbial agents in human clinical respiratory specimens from patients suspected of respiratory infection, aiding in diagnosis in conjunction with clinical, epidemiologic, and laboratory data. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 866.3981 in the Microbiology specialty. It carries product code QOF and is not an implant and not life-sustaining.
510(k) Clearances
25 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.