Definition: Flow Cytometer Specimen Processors Are Automated Or Semi-automated Workstations Designed To Be Used Alone Or In Combination With Manual Methods To Pipette, Dilute And Process Human Specimens In Preparation For Flow Cytometric Analysis.
| Device Type ID | 656 |
| Device Name | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis |
| Physical State | May Include Automated Processing Devices, Pipetting Devices, Diluting Devices. |
| Technical Method | Workstations Prepare Human Specimens For Flow Cytometric Analysis Using An Automated Process To Aspirate And Dispense Whole Blood, Lysing, Stabilizing And Fixative Reagents, Along With Monoclonal Antibodies And Florescent Molecules. |
| Target Area | May Include Peripheral Whole Blood Specimens, Isolated Mononuclear Cells, Bone Marrow, Body Fluids And Cells Dispersed From Tissues. |
| Regulation Description | Pipetting And Diluting System For Clinical Use. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2750 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PER |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 656 |
| Device | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis |
| Product Code | PER |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Pipetting And Diluting System For Clinical Use. |
| CFR Regulation Number | 862.2750 [🔎] |
| Device Problems | |
|---|---|
Failure To Sense | 2 |
Device Operates Differently Than Expected | 2 |
Fitting Problem | 1 |
Output Problem | 1 |
| Total Device Problems | 6 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | Jul-07-2017 |