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.
Reagents For Molecular Diagnostic Test Systems
Clinical Chemistry
Reagents for Molecular Diagnostic Test Systems is a kit containing reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in subsequent targeted re-sequencing of sample libraries for use as part of molecular diagnostic test systems. It is an FDA Class 1 device regulated under 21 CFR 862.3800, subject to general controls, within the Clinical Chemistry (CH) specialty. The product code is PFT. User-supplied analyte-specific reagents are required for library preparation targeting specific genomic regions of interest.
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.