Cleared Traditional

CINtec Histology

K212176 · Ventana Medical Systems, Inc. · Pathology
Dec 2021
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K212176 is an FDA 510(k) clearance for the CINtec Histology, a Cervical Intraepithelial Neoplasia (cin) Test System (Class II — Special Controls, product code PRB), submitted by Ventana Medical Systems, Inc. (Tucso, US). The FDA issued a Cleared decision on December 10, 2021, 151 days after receiving the submission on July 12, 2021. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1865.

Submission Details

510(k) Number K212176 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2021
Decision Date December 10, 2021
Days to Decision 151 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code PRB — Cervical Intraepithelial Neoplasia (cin) Test System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.1865
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.