PRB

Cervical Intraepithelial Neoplasia (Cin) Test System

Product code

PRB

Device name

Cervical Intraepithelial Neoplasia (Cin) Test System

Device class

Class 2

21 CFR

21 CFR 864.1865

Medical specialty

Pathology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

FDA classification definition

The p16 CIN test system is a qualitative immunohistochemistry (IHC) test to assess the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues. It is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of CIN. Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information.

Definition text from the FDA device classification database (U.S. federal government work, public domain).