Adamts13 Activity Test System
The ADAMTS13 activity test system is a qualitative or quantitative in vitro diagnostic device intended to detect ADAMTS13 enzyme activity in human blood specimens from patients being evaluated for thrombotic microangiopathy, aiding in the diagnosis and management of thrombotic thrombocytopenic purpura (TTP) when used alongside other clinical and laboratory findings. It is classified as FDA Class II (510(k) required) under regulation 864.7297, falling within the Hematology medical specialty. The product code is SAC. The device is not an implant and does not support life-sustaining functions.
Basic Information
- Product Code
- SAC
- Device Class
- FDA class 2
- Regulation Number
- 864.7297
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
Definition
An ADAMTS13 activity test system is a qualitative or quantitative in vitro diagnostic device intended to detect ADAMTS13 activity in human blood specimens collected from patients being evaluated for thrombotic microangiopathy. This device is indicated to aid in the diagnosis and management of patients being evaluated for thrombotic thrombocytopenic purpura in conjunction with other clinical and laboratory findings.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN230024 | Technozym ADAMTS13 Activity | Feb 28, 2024 | Unknown | Technoclone Herstellung von Diagnostika und Arzneimitteln Gm |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.