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.
Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells
Hematology
The Immunohistochemical Reagent for P63 Protein in Prostatic Basal Cell Nuclei is a monoclonal or polyclonal antibody used with routine immunohistochemical techniques, including heat-induced antigen retrieval, to qualitatively identify the p63 antigen in histological sections from formalin-fixed paraffin-embedded prostate tissue. The presence or absence of p63 staining aids pathologists in differential diagnosis of prostate cancer in conjunction with hematoxylin and eosin morphological findings. It is an FDA Class 1 device regulated under 21 CFR 864.1860 in the Hematology specialty, reviewed by the Pathology panel, with product code NTR, and is exempt from premarket notification under submission type 4. It is not an implant and does not carry life-sustaining support designation.
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.