Not Cleared Direct

DEN160019 - CINtec Histology (50 tests), CINtec Histology (250 tests) (FDA 510(k) Clearance)

Class II Pathology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160019 · Ventana Medical Systems, Inc. · Pathology device
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Mar 2017
Decision
285d
Days
Class 2
Risk

DEN160019 is an FDA 510(k) submission (not cleared) for the CINtec Histology (50 tests), CINtec Histology (250 tests). Classified as Cervical Intraepithelial Neoplasia (cin) Test System (product code PRB), Class II - Special Controls.

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Not Cleared (DENG) decision on March 4, 2017 after a review of 285 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1865 - the FDA pathology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 285 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Ventana Medical Systems, Inc. devices

Submission Details

510(k) Number DEN160019 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 23, 2016
Decision Date March 04, 2017
Days to Decision 285 days
Submission Type Direct
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 77d · This submission: 285d
Pathway characteristics

Device Classification

Product Code PRB Cervical Intraepithelial Neoplasia (cin) Test System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.