Cleared Traditional

K050063 - PROSTATE-63 CANCER DIAGNOSTIC TEST (FDA 510(k) Clearance)

Class I Pathology device.

K050063 · Asymmetrx · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
29d
Days
Class 1
Risk

K050063 is an FDA 510(k) clearance for the PROSTATE-63 CANCER DIAGNOSTIC TEST. Classified as Immunohistochemical Reagent, Antibody (monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells (product code NTR), Class I - General Controls.

Submitted by Asymmetrx (Amston, US). The FDA issued a Cleared decision on February 9, 2005 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Asymmetrx devices

Submission Details

510(k) Number K050063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2005
Decision Date February 09, 2005
Days to Decision 29 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 77d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NTR Immunohistochemical Reagent, Antibody (monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1860
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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.