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.
Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
Microbiology
The RT-qPCR Assay for mRNA Transcript Immune Biomarkers is a quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood, used to assess immune biomarker profiles. It is classified as FDA Class 2 under 21 CFR 866.3215 in the Microbiology specialty, requiring 510(k) premarket notification. The device provides information on host immune response to support clinical decision-making. Product code PRE; not an implant and not life-sustaining.
510(k) Clearances
4 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.