510(k) DEN230024

Technozym ADAMTS13 Activity by Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM — Product Code SAC

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: February 28, 2024
Date Received: April 6, 2023
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Adamts13 Activity Test System
Device Class: Class II
Regulation Number: 864.7297
Review Panel: HE
Submission Type

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.