Not Cleared Direct

DEN170030 - VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody (FDA 510(k) Clearance)

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

DEN170030 · Ventana Medical Systems · Pathology device
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Oct 2017
Decision
150d
Days
Class 2
Risk

DEN170030 is an FDA 510(k) submission (not cleared) for the VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (.... Classified as Lynch Syndrome Test System (product code PZJ), Class II - Special Controls.

Submitted by Ventana Medical Systems (Tucson, US). The FDA issued a Not Cleared (DENG) decision on October 27, 2017 after a review of 150 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1866 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Pathology review framework.

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Submission Details

510(k) Number DEN170030 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 30, 2017
Decision Date October 27, 2017
Days to Decision 150 days
Submission Type Direct
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 77d · This submission: 150d
Pathway characteristics

Device Classification

Product Code PZJ Lynch Syndrome Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1866
Definition The Lynch Syndrome Test System Is Used To Identify Loss Of Dna Mismatch Repair Proteins Or Microsatellite Instability In Tumor Tissue From Cancer Patients For The Purpose Of Identifying Patients Who May Benefit From Additional Testing For The Inherited Cancer Predisposition Lynch Syndrome
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.