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.
Candida Species Nucleic Acid Detection System
Microbiology
The Candida Species Nucleic Acid Detection System is a qualitative panel for the direct detection of multiple Candida species in whole blood specimens from patients with symptoms of or medical conditions predisposing them to invasive fungal infections, intended for the presumptive diagnosis of candidemia independent of blood culture. It is an FDA Class 2 device regulated under 21 CFR 866.3960, requiring 510(k) premarket notification, within the Microbiology (MI) specialty. The product code is PII. Concomitant blood cultures are required to recover organisms for susceptibility testing and further identification.
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.