Tru Liver Health Test Panel

The Tru Liver Health Test Panel is an in vitro diagnostic device used with the Tru Analyzer to measure three liver enzymes—Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT)—from lithium-heparinized whole blood samples. It is designed for use in clinical laboratories and point-of-care settings to aid physicians in diagnosing liver, bone, parathyroid, intestinal, and heart diseases in adults 18 years and older.

The device uses the same detection wavelengths (ALP: 405 nm; AST and ALT: 340 nm), factory-calibrated barcode calibration, and intended use settings as the predicate. Key differences include slightly lower analytical measuring ranges (ALP: 25–1,200 vs. 41–1,500 U/L; AST: 11–700 vs. 20–1,000 U/L), use of whole blood only rather than plasma or serum, and expanded reagent storage options (2–8°C or 15–25°C for up to 14 days vs. 2–8°C only).

CLSI EP05-A3 (precision), CLSI EP06-Ed2 (linearity), CLSI EP07-Ed3 (interference testing), CLSI EP09c-Ed3 (method comparison), CLSI EP17-A2 (detection limits), CLSI EP25-Ed2 (reagent stability), CLSI EP28-A3c (reference intervals), and CLSI EP37-Ed1 (supplemental interference tables). Electromagnetic compatibility and safety tested against IEC 61326-2-6:2020, IEC 61326-1:2020, FCC Part 15, and related standards.

Substantial equivalence is established through comparable performance testing demonstrating precision/reproducibility, linearity, detection limits, interference resistance, and analytical measuring ranges consistent with the predicate device (Skyla Comprehensive Metabolic Panel, K171971). Method comparison studies show strong correlation with FDA-cleared Roche Cobas results (R values 0.997–0.999 for all analytes), confirming the subject device is as safe and effective as the predicate.