Cleared Traditional

K212176 - CINtec Histology (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212176 · Ventana Medical Systems, Inc. · Pathology device
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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

Submission Details

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.

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.