| Device |
data acquisition software |
| Regulation Description |
Instrumentation for clinical multiplex test systems. |
| Definition |
Software that integrates a network of sample pooling instruments, and manages the overall blood analysis sample workflow. Software acquires and processes data from various donor screening, diagnostic, multiplex assay instruments. |
| Physical State |
Standalone software running on a PC or on a mobile platform. |
| Technical Method |
Software accesses various instruments either wirelessly or wired through the communication protocol defined by these instruments. Software retrieves data stored in these instruments and creates a workflow repository of the samples tested. |
| Target Area |
Systemic viral infection |
| Regulation Medical Specialty |
Clinical Chemistry |
| Review Panel |
Microbiology |
|---|
| Product Code | PQQ |
|---|
| Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
862.2570
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
