# DEN240025: VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)

- Pathway: De Novo (Direct)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Dec 5, 2024 after 190 days
- Product code: SDP (Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit)
- Device class: 2
- Regulation: 21 CFR 864.1861
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail Assay is a qualitative assay that is used to detect the expression of kappa and lambda immunoglobulin light chains in formalin-fixed paraffin embedded (FFPE) human hematolymphoid specimens by in situ hybridization (ISH). The assay is intended as an aid in the diagnosis of mature B-cell lymphomas and plasma cell neoplasms. The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is indicated for use when a biopsy of lymph node or bone marrow (core biopsy and clot section) indicates inconclusive results. It enables the assessment of both markers in the context of one another on a single slide as an aid in differentiating between a reactive process or B-cell lymphoma and plasma cell neoplasms. This is not a standalone test, and results should be evaluated by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests. This product is intended for in vitro diagnostic (IVD) use.

Source page: https://510kreport.com/device/DEN240025
Methodology: https://510kreport.com/methodology