21 CFR 862.3115 — Infliximab Test System
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3115
Identification
The Procise IFX assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of infliximab levels in venous serum in patients undergoing infliximab therapy, using the ProciseDx Analyzer. It is intended for use in a clinical laboratory as an aid in the management of patients with inflammatory bowel diseases (Crohn's disease and ulcerative colitis) being treated with infliximab.
Classification Rationale
Class II (Special Controls). The device is classified under 21 CFR 862.3115, Anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QXT | Infliximab Test System | 2 | 1 | |
| QYD | Adalimumab Assay | 2 | 1 |
