DEN130010 is an FDA 510(k) submission for the VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION). This device is classified as a Early Growth Response Gene 1 (egr1) Fish Probe Kit For Specimen Characterization (Class II - Special Controls, product code PDO).
Submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Not Cleared (DENG) decision on July 29, 2013.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1870. 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..
| 510(k) Number | DEN130010 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 09, 2013 |
| Decision Date | July 29, 2013 |
| Days to Decision | 111 days |
| Submission Type | Post-NSE |
| Review Panel | Pathology (PA) |
| Summary | - |
| Product Code | PDO - Early Growth Response Gene 1 (egr1) Fish Probe Kit For Specimen Characterization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.1870 |
| 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. |