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

Page Type

Product Code

Definition

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

Physical State

May include chromogenically or fluorescently labeled oligonucleotide mRNA probes targeting kappa and lambda light chain mRNA and required ancillary reagents.

Technical Method

Hematolymphoid cells of interest are hybridized with nucleic acid probes for determining kappa and lambda mRNA ratios using ISH a clinically validated algorithm to determine the immunoglobulin light chain restriction status. Hybridization may be performed manually or using an automated stainer.

Target Area

Human clinical hematolymphoid specimens, including formalin-fixed, paraffin-embedded bone marrow aspirates and lymphoid tissue specimens.

Regulation Medical Specialty

Hematology

Review Panel

Medical Genetics

Submission Type

510(K)

Device Classification

Class 2

Regulation Number

864.1861

GMP Exempt?

No

Summary Malfunction Reporting

Ineligible

Implanted Device

No

Life-Sustain/Support Device

No

Third Party Review

Not Third Party Eligible

MAUDE Alerts

View and Sign Up For MAUDE Alerts