QYD · Adalimumab Assay
Clinical Toxicology · 21 CFR 862.3115 · Class 2
Overview
| Product Code | QYD |
|---|---|
| Device Name | Adalimumab Assay |
| Regulation | 21 CFR 862.3115 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN220023 | Procise ADL | Procisedx, Inc. | Sep 29, 2023 | DENG |
Top Applicants
- Procisedx, Inc. — 1 clearance
