De Novo · Granted
GrantedVENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana Medical Systems, Inc. · SDP Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
Granted on Dec 5, 2024 as a new device type through De Novo after a 190-day review.
- Decided
- Dec 5, 2024
- Review
- 190 days
- Class
- Class II
- Product code
- SDP
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SDP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SDP devicesSDP Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SDP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SDP
Too few SDP 510(k)s in any year since 2007 to give a median.
Recalls per year · SDP
No recall names SDP since 2007.
Adverse event reports per year · SDP
No MAUDE report names SDP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (161 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240025 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240025: VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240025
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026