Not Cleared Direct

DEN240025 - VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (FDA 510(k) Clearance)

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

DEN240025 · Ventana Medical Systems, Inc. · Pathology device
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Dec 2024
Decision
190d
Days
Class 2
Risk

DEN240025 is an FDA 510(k) submission (not cleared) for the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001). Classified as Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit (product code SDP), Class II - Special Controls.

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Not Cleared (DENG) decision on December 5, 2024 after a review of 190 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1861 - 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.

View all Ventana Medical Systems, Inc. devices

Submission Details

510(k) Number DEN240025 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 29, 2024
Decision Date December 05, 2024
Days to Decision 190 days
Submission Type Direct
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 77d · This submission: 190d
Pathway characteristics

Device Classification

Product Code SDP Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1861
Definition A Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization (ish) Mrna Probe Is Intended As An Aid In The Identification Of Hematolymphoid Neoplasms Using In Situ Hybridization. A Kappa And Lambda Ish Mrna Probe Cocktail Is Indicated For Use When A Hematolymphoid Biopsy (e.g., Bone Marrow, Lymphoid Tissue) Yields Inconclusive Results. The Assay Is Intended As An Aid In The Diagnosis Of Mature B-cell Lymphomas And Plasma Cell Neoplasms
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.