SAC · Adamts13 Activity Test System
Hematology · 21 CFR 864.7297 · Class 2
Overview
| Product Code | SAC |
|---|---|
| Device Name | Adamts13 Activity Test System |
| Regulation | 21 CFR 864.7297 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
The Technozym ADAMTS13 Activity assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative determination of ADAMTS13 activity in platelet-poor human citrated plasma. It is used in conjunction with other clinical and laboratory findings as an aid in the diagnosis of thrombotic thrombocytopenic purpura (TTP) in adult and pediatric patients being evaluated for thrombotic microangiopathy (TMA).
Classification Rationale
Class II with special controls. The device is classified as Class II because general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, but the risks can be mitigated by special controls including design verification, validation, and specific labeling requirements.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN230024 | Technozym ADAMTS13 Activity | Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM | Feb 28, 2024 | DENG |
Top Applicants
- Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM — 1 clearance
