Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart B — Biological Stains](/submissions/HE/subpart-b%E2%80%94biological-stains) → [21 CFR 864.1861](/submissions/HE/subpart-b%E2%80%94biological-stains/864.1861) → SDP — Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

# SDP · Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

_Hematology · 21 CFR 864.1861 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94biological-stains/SDP

## Overview

- **Product Code:** SDP
- **Device Name:** Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
- **Regulation:** [21 CFR 864.1861](/submissions/HE/subpart-b%E2%80%94biological-stains/864.1861)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is a qualitative mRNA reagent designed to detect the expression of kappa and lambda immunoglobulin light chains in formalin-fixed paraffin embedded (FFPE) human hematolymphoid specimens (lymph node and bone marrow) by in situ hybridization (ISH). It is intended as an aid in the diagnosis of mature B-cell lymphomas and plasma cell neoplasms, specifically when a biopsy indicates inconclusive results, by enabling the assessment of both markers on a single slide to differentiate between a reactive process or B-cell lymphoma and plasma cell neoplasms.

## Classification Rationale

Class II (special controls). The device is classified under 21 CFR 864.1861 as a hematolymphoid neoplasm immunoglobulin mRNA in situ hybridization detection device.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN240025](https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94biological-stains/SDP/DEN240025.md) | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) | Ventana Medical Systems, Inc. | Dec 5, 2024 | DENG |

## Top Applicants

- Ventana Medical Systems, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94biological-stains/SDP](https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94biological-stains/SDP)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com