Prostate-63 Cancer Diagnostic Test

K050063510(k) TraditionalCleared Feb 9, 200529-day reviewClass I21 CFR 864.1860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Asymmetrx · NTR Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

Cleared on Feb 9, 2005 after a 29-day review. The FDA summary names no predicate by number.

Decided: Feb 9, 2005
Review: 29 days
Class: Class I
Product code: NTR
Recalls: None
Predicates: 0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K050063Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All NTR devices

NTR Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NTR

FDA has decided no NTR device since 2007.

Median 510(k) review, days · NTR

Too few NTR 510(k)s in any year since 2007 to give a median.

Recalls per year · NTR

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NTR

1in 2022

2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code NTR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	1	0
2016	—	0	1
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

Read the full statement (128 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050063 · printed Nov 5, 2026

Cite this page

510(k) Report. “K050063: Prostate-63 Cancer Diagnostic Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050063

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026