Cervical Intraepithelial Neoplasia (Cin) Test System
PRB · Class II — Moderate Risk (510(k) clearance required) · Pathology · 21 CFR 864.1865
Classification
FDA Product Code
PRB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 864.1865
Review panel
PA
Medical specialty
Pathology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.