DeviceClearance

Product code PRB— Pathology

CINtec Histology

Classification name
Cervical Intraepithelial Neoplasia (Cin) Test System
Device class
Class 2
Regulation
21 CFR 864.1865
Advisory panel
Pathology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PRB under 21 CFR 864.1865, via openFDA

Market context for product code PRB

FDA has cleared 2 devices under product code PRB between 2017 and 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PRB

Recent clearances under product code PRB

Data sourced from openFDA. This site is unofficial and independent of the FDA.