510(k) DEN240025
DEN240025 is an FDA 510(k) premarket notification submitted by Ventana Medical Systems, Inc. for the device "VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)". The FDA issued a decision of De Novo Granted on December 5, 2024. The device falls under product code SDP (Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit), a Class II device regulated under 21 CFR 864.1861. Ventana Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 5, 2024
- Date Received
- May 29, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
- Device Class
- Class II
- Regulation Number
- 864.1861
- Review Panel
- MG
- Submission Type
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