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U.S. Department of Health and Human Services

Product Classification

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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 CodePDI
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 Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible