DEN240025 is an FDA 510(k) submission for the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001). This device is classified as a Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit (Class II - Special Controls, product code SDP).
Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Not Cleared (DENG) decision on December 5, 2024.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1861. 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.
| 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 | — |
| Product Code | SDP — Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit |
| Device Class | Class II - 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 |