Blood Volume Analyzer (200)

The Daxor BVA-200 is an automated system that measures red cell mass, plasma volume, and total blood volume in adults using the indicator dilution technique with I-131 labeled human serum albumin as a tracer. It is an in vitro diagnostic device composed of a microprocessor, software, touchscreen, and gamma counter, intended for use in clinical laboratory settings by laboratory technicians under prescription.

The BVA-200 differs from the predicate BVA-100 in that it analyzes whole blood samples rather than requiring plasma fractionation, uses a modern rugged tablet computer with touchscreen instead of 1990s-era desktop computer setup, incorporates enhanced automated internal quality control, can be battery or mains powered, and is portable in a custom Pelican case. Both devices use identical indicator dilution mathematics, detect I-131 concentrations quantitatively based on gamma emissions, and accommodate delayed measurements up to 48 hours.

Not stated in this summary.

Substantial equivalence is established through a clinical comparison study of 319 unique measurements between the BVA-200 and BVA-100 using patient blood samples, demonstrating high Pearson correlation coefficients (0.99) across all measured parameters (TBV, RCV, PV, nHct) with slopes near 1.0 and minimal intercepts. The study confirmed that the effects of K3EDTA anticoagulant in whole blood are equivalent to the predicate's use of plasma. Comprehensive performance testing demonstrated precision with total coefficient of variation below 3.6%, linearity with maximum deviation ≤8%, and robustness against hemolysis, shipping stress, and temperature variations, establishing functional equivalence for the same intended use of blood volume measurement.