FDA product code SAC: Adamts13 Activity Test System
SAC is the FDA product code for adamts13 activity test system. It is a Class II device, regulated under 21 CFR 864.7297 and reviewed by the Hematology panel. Devices under SAC reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Adamts13 Activity Test System |
| Device class | Class II |
| Regulation | 21 CFR 864.7297 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for SAC devices
openFDA lists no recalls for product code SAC.
Frequently asked questions
What is FDA product code SAC?
SAC is the FDA product code for adamts13 activity test system. It is a Class II device, regulated under 21 CFR 864.7297 and reviewed by the Hematology panel.
What device class is SAC?
Class II, regulation 21 CFR 864.7297. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SAC
- Run a recall and safety report across every SAC manufacturer
- Watch product code SAC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times