Tru Kidney Health Test Panel; Tru Analyzer

The Tru Kidney Health Test Panel is an in vitro diagnostic device that measures Creatinine (CRE) and Blood Urea Nitrogen (BUN) in lithium-heparinized venous whole blood using the Tru Analyzer. The device calculates estimated Glomerular Filtration Rate (eGFR) from the creatinine result and is intended for use in clinical laboratory or point-of-care settings to aid physicians in diagnosing renal disease, monitoring renal dialysis, and identifying certain renal and metabolic disorders in adults 18 years or older.

The Tru Analyzer is a benchtop automated, multi-assay integrated system with an absorbance reader, bead scanner, and cell imager. Key differences from the predicate include a larger form factor (12" W x 20" D x 17" H vs. 8.8" W x 11.2" D x 11.8" H), use of a Xenon-arc stroboscopic lamp and CMOS array detector instead of LED and photodiode, broader operating temperature range (15-30°C vs. 10-32°C), larger sample volume (300 µL vs. 200 µL), and longer test time (≤30 minutes vs. 15 minutes). The creatinine analytical measuring range is 0.2-20 mg/dL and BUN is 2-100 mg/dL.

The submission cites CLSI standards including EP05-A3 (precision), EP06-Ed.2 (linearity), EP07-Ed.3 and EP37-Ed.1 (interference testing), EP09c-Ed.3 (method comparison), EP17-A2 (detection limits), EP25-Ed.2 (reagent stability), and EP28-A3c (reference intervals). The Tru Analyzer also complies with IEC 61326-2-6:2020, IEC 61326-1:2020, ETSI EN standards, CFR47 FCC Part 15, ICES-003, and RSS-Gen standards for electromagnetic compatibility and safety.

Substantial equivalence is established through comparative performance testing demonstrating that the Tru Kidney Health Test Panel achieves acceptable precision (CV% ≤4.6% for all analytes), linearity across the claimed measuring ranges, and method comparison results highly correlated with the Roche Cobas comparator (R=0.999 for creatinine, R=0.995 for BUN). The device uses the same detection method (photometric/colorimetric), same assay temperature (37°C), and comparable intended use and specimen type as the predicate devices, with performance characteristics confirming it is as safe and effective as the predicate devices.