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
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Cervical Intraepithelial Neoplasia (cin) Test System Devices (Product Code PRB)

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

About Product Code PRB - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code PRB since 2017, with 1 receiving FDA clearance (average review time: 218 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

PRB devices are reviewed by the Pathology panel. Browse all Pathology devices →