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.
| Device Type ID | 3150 |
| Device Name | Data Acquisition Software |
| 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 Description | Instrumentation For Clinical Multiplex Test Systems. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PQQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3150 |
| Device | Data Acquisition Software |
| Product Code | PQQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Instrumentation For Clinical Multiplex Test Systems. |
| CFR Regulation Number | 862.2570 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STRATEC BIOMEDICAL UK LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Tosoh Smd Inc | II | Feb-22-2017 |