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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Antigen, Inflammatory Response Marker, Sepsis
Microbiology
The Sepsis Inflammatory Response Marker Antigen device is an immunoluminometric assay used to determine the concentration of procalcitonin (PCT) in human serum and plasma, serving as a biomarker for the assessment of sepsis and bacterial infections. PCT levels are used to aid clinical decisions regarding antibiotic therapy and to monitor the course of infection. It is an FDA Class 2 device regulated under 21 CFR 866.3210 in the Microbiology specialty, with product code NTM, requiring 510(k) clearance. It is not an implant and does not carry a life-sustaining support flag.
510(k) Clearances
3 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.