21 CFR 864.1861 — Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

Hematology (HE) · Part 864 Subpart B—Biological Stains · § 864.1861

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.

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