STA Satellite Max®

The STA Satellite Max® is a fully automatic clinical laboratory analyzer that performs qualitative and quantitative in vitro coagulation tests on human blood plasma samples (3.2% citrate). It measures clotting time, chromogenic, and immunoassay parameters to diagnose coagulation abnormalities and monitor anticoagulant therapy in hospital and clinical laboratory settings.

The device uses two measurement principles: chronometric (measuring oscillation amplitude of a metal ball in a cuvette) and photometric (light absorption at 405 nm or 540 nm). Key design elements include a PDR pipetting system, single needle for samples and reagents, 16-position reagent carousel, and automatic sample dilution. Modern upgrades include Windows 10 operating system, 464 GB data storage (vs. 2 GB), updated connectivity ports, and modularized software architecture, but core analytical subsystems remain unchanged.

Performance validation followed CLSI EP05-A3 (precision), CLSI EP06-Ed2 (linearity), CLSI EP09c (method comparison), CLSI EP17-A2 (limits of detection and quantification), and CLSI H47-A2/H48 (prothrombin time testing). Studies assessed repeatability, reproducibility across multiple sites, and factor sensitivity.

The STA Satellite Max® is substantially equivalent to the predicate STA Satellite® (K082248) because both devices share identical intended use, sample matrix, measurement principles, fluidic architecture, and operating environment. Method comparison studies demonstrated excellent correlation (r >0.989) and regression slopes near 1.0 across all assays. Hardware and software modernization do not affect analytical performance or clinical functionality—the core analytical engine, measurement algorithms, and test capabilities are unchanged.