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 Myelodyspla
| Device Type ID | 4906 |
| Device Name | Early Growth Response Gene 1 (egr1) Fish Probe Kit For Specimen Characterization |
| 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 A |
| Target Area | Bone Marrow Specimens |
| Regulation Description | Early Growth Response 1 (EGR1) Gene Fluorescence In-situ Hybridization (FISH) Test System For Specimen Characterization. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 864.1870 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PDO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |