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Diagnostica Stago Nabs FDA 510(k) Clearance for Coagulation Analyzers

NEW YORK – Diagnostica Stago said Monday it gained US Food and Drug Administration 510(k) clearance for the newest versions of its Max Generation analyzers used to aid in the diagnosis of coagulation abnormalities or monitoring of anticoagulant therapy.

The French firm said its fully automated STA R Max3 and STA Compact Max3 analyzers are designed to provide clot-based, immunoturbidimetric, and colorimetric testing. They incorporate the firm's proprietary viscosity-based detection system, a comprehensive pre-analytical module designed to automate sample management and reduce interventions, and the firm's expert pre-analytical check system to examine samples for proper fill volumes, hemolysis, icterus, and lipemia.

Stago said the instruments, which use a Windows 10-based operating system, also incorporate cybersecurity safeguards that protect the system and data privacy in compliance with international guidelines and allow deployment of new applications to support laboratory management.

"The Max Generation3 family was designed to reduce hands-on time, limit maintenance operations, ensure reliability, increase cybersecurity safeguards, and deliver unmatched quality results," Stago North America CEO Philippe Barroux said in a statement.

The firm said the STA R Max3 instrument is designed for high-volume and reference laboratories, where the instrument can connect with all total laboratory automation lines on the market as well as to Stago's STA WorkCell Max coagulation automation line. The STA Compact Max3 instrument is designed to offer midsize laboratories the same test menu, quality of results, and efficiencies in a smaller footprint.

Stago said it plans to launch the fully automated instruments in the US market at the 2023 American Association for Clinical Chemistry Scientific Meeting July 25-27 in Anaheim, California.