510(k) Report

FDA product code · Pathology

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

NTRClass I21 CFR 864.1860510(k) exempt1 decision since 20051 recall

FDA lists NTR as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2005. 1 recall names this code; it is not Class I.

MONOCLONAL OR POLYCLONAL ANTIBODY THAT RECOGNIZES THE HUMAN P63 PROTEIN IN THE NUCLEUS OF PROSTATIC BASAL CELLS USING ROUTINE IMMUNOHISTOCHEMICAL TECHNIQUES, INCLUDING HEAT-INDUCED ANTIGEN EPITOPE RETRIEVAL. THIS TEST IS INTENDED FOR LABORATORY USE TO QUALITATIVELY IDENTIFY THE P63 ANTIGEN IN HISTOLOGICAL SECTIONS FROM FORMALIN-FIXED PARAFFIN-EMBEDDED SAMPLES OF NORMAL AND/OR PATHOLOGICAL PROSTATE TISSUE OBTAINED…

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

FIG. A — Illustration, pathology panel

Twenty years of NTR at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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

2015: 1
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

2016: 12022: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—10
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — NTR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NTR? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

What has FDA decided in NTR lately?

  • K050063Prostate-63 Cancer Diagnostic TestAsymmetrx · 2005

The one NTR decision →

What has been recalled in NTR lately?

  • Z-0322-2016Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and…Lab Vision Corporation · Oct 27, 2015Class III

Related product codes

Other codes under 21 CFR 864.1860.

MXZ Immunohistochemistry Assay, Antibody…LPJ Kit, Assay, Estrogen ReceptorQZJ Immunohistochemistry Assay, Antibody, Claudin 18NQN Microscope, Automated, Image Analysis…NJT Immunohistochemistry Reagents And KitsLPI Kit, Assay, Progesterone ReceptorNBK System, Test, (Ihc), Tumor Marker, Monitoring…QNH Immunohistochemistry Test, Dna Mismatch Repair…NJW Control Material, Her-2/Neu…OEO Automated Digital Image Manual Interpretation…NOT Microscope, Automated, Image Analysis…NKF Immunohistochemistry Antibody Assay, C-Kit