# DEN230024: Technozym ADAMTS13 Activity

- Pathway: De Novo (Direct)
- Applicant: Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM
- Decided: Feb 28, 2024 after 328 days
- Product code: SAC (Adamts13 Activity Test System)
- Device class: 2
- Regulation: 21 CFR 864.7297
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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. The assay is intended to be 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).

Source page: https://510kreport.com/device/DEN230024
Methodology: https://510kreport.com/methodology