June 21, 2023—Diagnostica Stago announced FDA 510(k) clearance of its Max Generation 3 analyzers, the STA R Max 3 and STA Compact Max 3. The analyzers feature a mechanical viscosity-based detection system and a preanalytical module that aims to ensure quality results with fewer interventions and flags, and efficient, automated sample management. The new expert preanalytical check controls fill volumes and detects hemolysis, icterus, and lipemia in advance of testing with no additional cuvettes, reagents, or plasma consumed. Additional efficiencies are gained with a maintenance-free, single-resolution pipetting system. The analyzers are powered by a Windows 10 operating system and protected by cybersecurity safeguards such as user-rights management.
STA R Max 3 is designed for high-volume and reference laboratories and can connect to total laboratory automation lines or the company’s STA Workcell Max with no instrument modifications. STA Compact Max 3 is designed for midsize laboratories and offers the same test menu, quality of results, and efficiencies of the STA R Max 3 in a smaller footprint.
Max Generation 3 analyzers will be introduced to the U.S. market at the 2023 AACC Annual Scientific Meeting, July 23–27, in Anaheim, Calif.