PRB · Class II · 21 CFR 864.1865

FDA Product Code PRB: Cervical Intraepithelial Neoplasia (cin) Test System

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.

Leading manufacturers include Ventana Medical Systems, Inc..

2
Total
1
Cleared
218d
Avg days
2017
Since

List of Cervical Intraepithelial Neoplasia (cin) Test System devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Dec 10, 2021
CINtec Histology
K212176
Ventana Medical Systems, Inc.
Pathology · 151d
Not Cleared Mar 04, 2017
CINtec Histology (50 tests), CINtec Histology (250 tests)
DEN160019
Ventana Medical Systems, Inc.
Pathology · 285d

How to use this database

This page lists all FDA 510(k) submissions for Cervical Intraepithelial Neoplasia (cin) Test System devices (product code PRB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Pathology FDA review panel. Browse all Pathology devices →