# K050063: Prostate-63 Cancer Diagnostic Test

- Pathway: 510(k) (Traditional)
- Applicant: Asymmetrx
- Decided: Feb 9, 2005 after 29 days
- Product code: NTR (Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells)
- Device class: 1
- Regulation: 21 CFR 864.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
For In Vitro Diagnostic Use. The Prostate-63 Cancer Diagnostic Test features a mouse monoclonal antibody, clone 4A4, that recognizes the human p63 protein in the nucleus of prostatic basal cells and urothelial tissues. This test is intended for laboratory use to qualitatively identify by immunohistochemistry the p63 antigen in histological sections from formalin-fixed paraffin-embedded tissue of normal and/or pathological prostate tissue obtained by needle biopsy or surgical procedures. The presence or absence of p63 staining aids the pathologist in the differential diagnosis of prostate cancer in conjunction with morphological findings seen with hematoxylin and eosin staining complemented by proper controls. The clinical interpretation of any staining or its absence should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Source page: https://510kreport.com/device/K050063
Methodology: https://510kreport.com/methodology