| Device |
beta 2-microglobulin apheresis column |
| Definition |
Relief of symptoms of clinically diagnosed dialysis-related amyloidosis (DRA). |
| 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 with capacity ranging from 150 ml to 350 ml and extracorporeal volume ranging from 65 ml to 177 ml. |
| 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 |
|---|
| Product Code | PDI |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| Submission Type |
HDE - Humanitarian Device Exemption
|
|---|
| Device Class |
HDE
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
