| Device |
early growth response gene 1 (egr1) fish probe kit for specimen characterization |
| Regulation Description |
Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization. |
| Definition |
The EGR1 FISH Probe Kit for specimen characterization detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. This assay is used to characterize bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome. The assay results are to be interpreted by a qualified pathologist or cytogeneticist. |
| Physical State |
May include LSI EGR1 DNA probes, hybridization buffers, DAPI counterstain |
| Technical Method |
Bone marrow cells from AML patients attached to microscope slides using standard cytogenetic procedures are used for this assay. The resulting specimen DNA is denatured to single-stranded form and subsequently allowed to hybridize with the LSI EGR1 and LSI D5S23, D5S721 probes. Following hybridization, the unbound probe is removed by a series of washes, and the nuclei are counterstained with DAPI, a DNA-specific stain that fluoresces blue. Hybridization of the LSI EGR1 and LSI D5S23, D5S721 probes is viewed using a fluorescence microscope equipped with appropriate excitation and emission filters, allowing visualization of the orange and green fluorescent signals. |
| Target Area |
Bone marrow specimens |
| Regulation Medical Specialty |
Hematology |
| Review Panel |
Pathology |
|---|
| Product Code | PDO |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.1870
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
|
Third Party Review
|
Accredited Persons
|
