| Device |
device, automated cell locating, bone marrow |
| 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. |
| Physical State |
The device consists of a digital scanner, computer with display (processing unit), and software to analyze and present the images to the operator. |
| Technical Method |
The device enables scanning all the relevant parts of a slide. A high-resolution camera captures multiple images of the bone marrow aspirate smear, and the device presents the scanned images to operator. |
| Target Area |
Bone marrow aspiration smears |
| Regulation Medical Specialty |
Hematology |
| Review Panel |
Hematology |
|---|
| Product Code | SAL |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Immunology and Hematology Devices
(DIHD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.5261
|
|---|
| 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 |
