Diagnostica Stago receives US FDA clearance for Max Generation 3 family of automated hemostasis systems

June 20, 2023
Update from Stago.

Diagnostica Stago, Inc. (Stago) announced 510(k) clearance of the Max Generation3 family of analyzers including STA R Max3 and STA Compact Max3. The Max Generation analyzers deliver an exclusive combination of Stago’s Viscosity-Based Detection System (VBDS) mechanical clot methodology and a comprehensive pre-analytical module that ensures quality results with fewer interventions, fewer flags, and efficient, automated sample management. Max Generation3 analyzers will be introduced to the US market at the 2023 AACC Scientific Meeting in Anaheim, California, July 25-27, 2023.

STA R Max3 and STA Compact Max3 are intentionally designed to meet workforce challenges of today’s laboratories. Stago’s new Expert Preanalytical Check (EPC) ensures pre-analytical sample integrity with checks for proper fill volumes, hemolysis, icterus, and lipemia in advance of testing with no additional cuvettes, reagents, or plasma consumed. EPC joins the power of VBDS to ensure that laboratorians can report the right result, the first time with confidence for clot-based, immunoturbidimetric, and colorimetric test methodologies.

Each STA R Max3 and STA Compact Max3 is powered by a Windows 10 operating system and protected by cybersecurity safeguards such as user-rights management to ease the minds of laboratorians and IT departments alike. The security of the system and privacy of data is implemented by design to comply with international guidelines and to enable deployment of new applications that support laboratory management such as remote expert support.

Stago release