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.
Procalcitonin Assay
Microbiology
The Procalcitonin Assay is an in vitro diagnostic device that measures procalcitonin levels in blood to aid in decision-making regarding antibiotic therapy initiation and discontinuation for inpatients or emergency department patients with suspected or confirmed lower respiratory tract infections, including community-acquired pneumonia, acute bronchitis, and acute exacerbation of COPD. It is classified as FDA Class 2 under 21 CFR 866.3215 in the Microbiology specialty, requiring 510(k) clearance. Product code PRI; not an implant and not life-sustaining.
510(k) Clearances
8 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.