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510(k) DEN160019

CINtec Histology (50 tests), CINtec Histology (250 tests) by Ventana Medical Systems, Inc. — Product Code PRB

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 4, 2017
Date Received
May 23, 2016
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cervical Intraepithelial Neoplasia (Cin) Test System
Device Class
Class II
Regulation Number
864.1865
Review Panel
PA
Submission Type

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.

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Other clearances for product code PRB

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