Product code SAC— Hematology

Technozym ADAMTS13 Activity

Classification name: Adamts13 Activity Test System
Device class: Class 2
Regulation: 21 CFR 864.7297
Advisory panel: Hematology
Total cleared: 1
First cleared: 2024-02-28
Most recent: 2024-02-28

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code SAC under 21 CFR 864.7297, via openFDA

Market context for product code SAC

FDA has cleared 1 device under product code SAC, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SAC

Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM1 clearance

Recent clearances under product code SAC

DEN230024 — Technozym ADAMTS13 ActivityTechnoclone Herstellung Von Diagnostika Und Arzneimitteln GM·2024-02-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.