DeviceClearance

Product code NTR— Hematology

PROSTATE-63 CANCER DIAGNOSTIC TEST

Classification name
Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells
Device class
Class 1
Regulation
21 CFR 864.1860
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

FDA classification definition

“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 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.”

— U.S. Food and Drug Administration, device classification record for product code NTR under 21 CFR 864.1860, via openFDA

Market context for product code NTR

FDA has cleared 1 device under product code NTR, all in 2005, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code NTR

Recent clearances under product code NTR

Data sourced from openFDA. This site is unofficial and independent of the FDA.