Tru Kidney Health Test Panel; Tru Analyzer

Tru Kidney Health Test Panel; Tru Analyzer is an FDA 510(k)-cleared medical device (K251058) manufactured by Truvian Health. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 25, 2025. Regulation: 8.