SES · Non-Factor Replacement Product Test System
Hematology · 21 CFR 864.7298 · Class 2
Overview
| Product Code | SES |
|---|---|
| Device Name | Non-Factor Replacement Product Test System |
| Regulation | 21 CFR 864.7298 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
The ConcizuTrace ELISA is a manual, quantitative enzyme-linked immunosorbent assay (ELISA) intended for the measurement of concizumab concentration in human 3.2% citrated plasma samples from Hemophilia A and B patients after 4 weeks from the initiation of treatment with concizumab. The measurement is used for dose adjustment decisions in accordance with the drug label. The assay is performed by qualified healthcare professionals using a qualified microplate reader.
Classification Rationale
Class II (special controls). The device is classified as a non-factor replacement product test system under 21 CFR 864.7298. The FDA determined that general controls alone are insufficient to mitigate the risks of false test results, failure of the system to perform as intended, or failure to correctly interpret results, which could lead to inappropriate or delayed treatment decisions. Special controls, in addition to general controls, provide reasonable assurance of safety and effectiveness.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN240035 | ConcizuTrace ELISA | Randox Laboratories, Ltd. | May 22, 2025 | DENG |
Top Applicants
- Randox Laboratories, Ltd. — 1 clearance
