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.
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
Immunology
The CFTR Gene Variant Gene Sequence Detection System is a molecular diagnostic device used to sequence specified regions of the CFTR gene to detect variants, intended as an aid in confirmatory diagnostic testing for individuals with suspected cystic fibrosis, atypical CF presentations, or when other mutation panels have failed to identify both causative mutations. It is an FDA Class 2 device regulated under 21 CFR 866.5900, requiring 510(k) clearance, classified under the Immunology (IM) specialty with Pathology (PA) panel review. The product code is PFS. The device is not intended for carrier screening, newborn screening, prenatal diagnosis, or stand-alone diagnostic use.
510(k) Clearances
1 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.