Definition: Relief Of Symptoms Of Clinically Diagnosed Dialysis-related Amyloidosis (DRA).
| Device Type ID | 2228 |
| Device Name | Beta 2-microglobulin Apheresis Column |
| Physical State | The Beta 2-microglobulin Apheresis Column Is An Adsorbent Column Containing Porous, Spherical Cellulose Beads With Covalently Linked Hexadecyl Groups As Ligands. The Size Of The Pores On The Beads Is About 460 Um. The Device Comes In Multiple Models |
| Technical Method | The Device Adsorbs Beta 2-microglobulin By The Combined Use Of Hydrophobic Interaction And The Appropriate Pore Size On Cellulose Beads. The Pore Size Limits The Size Of Proteins And Peptides Adsorbed By The Column To Be Between 4 And 20 KDa. |
| Target Area | External Communicating Device In Contact With Circulating Blood. |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | PDI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2228 |
| Device | Beta 2-microglobulin Apheresis Column |
| Product Code | PDI |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 6 |
| Total Device Problems | 6 |