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U.S. Department of Health and Human Services

Product Classification

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Device immunohistochemical reagent, antibody (monoclonal or polyclonal) to p63 protein in nucleus of prostatic basal cells
Regulation Description Immunohistochemistry reagents and kits.
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.
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodeNTR
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 864.1860
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible