Cleared Traditional

K212176 - CINtec Histology

K212176 is an FDA 510(k) clearance for CINtec Histology, manufactured by Ventana Medical Systems, Inc.. The device is a Class 2 Pathology device with product code PRB cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K212176 · Ventana Medical Systems, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
151d
Days
Class 2
Risk

K212176 is an FDA 510(k) clearance for the CINtec Histology. 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 Cleared decision on December 10, 2021 after a review of 151 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ventana Medical Systems, Inc. devices

FDA 510(k) Submission Details - K212176

510(k) Number K212176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 77d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PRB Device Classification - Class 2, Special Controls

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.