PRB — Cervical Intraepithelial Neoplasia (Cin) Test System Class II
Classification Details
- Product Code
- PRB
- Device Class
- Class II
- Regulation Number
- 864.1865
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
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.