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.
Docetaxel / Paclitaxel Assay
Unknown
The Docetaxel/Paclitaxel Assay is a diagnostic test intended to measure levels of the chemotherapy drugs Docetaxel or Paclitaxel in the blood, used in therapeutic drug monitoring for cancer patients receiving taxane-based chemotherapy. It is currently unclassified (not classified by FDA panel action) and reviewed by the Clinical Toxicology panel; it does not have an assigned regulation number. The device received a "not classified" determination (unclassified reason code 3), meaning its classification has not been established through the standard process. Product code PRF; not an implant and not life-sustaining.
No 510(k) clearances found for "PRF". Try a different K-number, product code, or device name.
What 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.