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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Cervical Intraepithelial Neoplasia (Cin) Test System
Pathology
The Cervical Intraepithelial Neoplasia (CIN) Test System is a qualitative immunohistochemistry (IHC) test that assesses p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues as an adjunct to H&E staining, intended to improve consistency in the diagnosis of cervical intraepithelial neoplasia. It is classified as FDA Class 2 under 21 CFR 864.1865 in the Pathology specialty, requiring 510(k) premarket notification. Diagnosis must be based on H&E-stained slides and other clinical and laboratory information. Product code PRB; not an implant and not life-sustaining.
510(k) Clearances
2 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.