DEN230034 is an FDA 510(k) submission for the X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application. This device is classified as a Device, Automated Cell Locating, Bone Marrow (Class II - Special Controls, product code SAL).
Submitted by Scopio Labs , Ltd. (Tel-Aviv, IL). The FDA issued a Not Cleared (DENG) decision on March 22, 2024.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5261. An Automated Cell-locating Device For Bone Marrow Aspirate Is An In Vitro Diagnostic Device Intended For Prescription Use That Automatically Locates And Presents Images Of Hematopoietic Cells On A Bone Marrow Aspirate Smear Obtained From Patients Being Evaluated For Hematologic Diseases. The Device Assists Operators To Identify And Classify Each Cell According To Type..
| 510(k) Number | DEN230034 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 28, 2023 |
| Decision Date | March 22, 2024 |
| Days to Decision | 329 days |
| Submission Type | Direct |
| Review Panel | Hematology (HE) |
| Summary | - |
| Product Code | SAL - Device, Automated Cell Locating, Bone Marrow |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5261 |
| Definition | An Automated Cell-locating Device For Bone Marrow Aspirate Is An In Vitro Diagnostic Device Intended For Prescription Use That Automatically Locates And Presents Images Of Hematopoietic Cells On A Bone Marrow Aspirate Smear Obtained From Patients Being Evaluated For Hematologic Diseases. The Device Assists Operators To Identify And Classify Each Cell According To Type. |