Definition: Instrument Used To Create Pools Of Whole Blood, Whole Blood Lysates, Serum, And /or Plasma, For Use In Blood Donor Screening Tests. May Include Sample Preparation Steps Such As Lysing Of Whole Blood Samples.
| Device Type ID | 679 |
| Device Name | Automated Platform Consisting Of Software And Instrumentation For Pooling And/or Lysing Donor Blood, Serum, Or Plasma |
| Physical State | Computer Controlled System Composed Of A Pipetting Instrument And Software, With A Work Surface For Pipettors, Reagents, And Various Tubes (sample, Intermediate, Pooling) To Facilitate The Pooling Workflows. May Include Lysis And Other Sample Prepara |
| Technical Method | Automated Lysis And/or Pooling Platform Consisting Of Pipetting And Sample Preparation Instrument And Software |
| Target Area | Blood, Serum, Or Plasma |
| 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)
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| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2750 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | QBZ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |