| Device |
kappa and lambda immunoglobulin light chain in situ hybridization mrna probe detection kit |
| 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 |
Molecular Genetics |
|---|
| Product Code | SDP |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.1861
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
