Core Metabolic

The Core Metabolic panel is an in vitro diagnostic device that quantitatively measures glucose, total protein, and albumin in lithium-heparinized venous whole blood samples. It is used on the TruVerus analyzer for clinical laboratory and point-of-care settings to aid physicians in diagnosing and treating carbohydrate metabolism disorders, liver/kidney/bone marrow diseases, and nutritional disorders in adults 18 years and older.

The device uses photometric/colorimetric detection at specific wavelengths (glucose 340 nm, total protein 550 nm, albumin 628 nm) with analytical measuring ranges of 10–450 mg/dL for glucose, 2.0–11.5 g/dL for total protein, and 1.0–6.5 g/dL for albumin. Calibrators are traceable to NIST reference materials, and reagents are stored at 2–8°C or 15–25°C for up to 14 days.

Performance testing followed CLSI EP05-A3 (precision), CLSI EP06 Ed.2 (linearity), CLSI EP07 Ed.3 (interference), CLSI EP09c Ed.3 (method comparison), CLSI EP17-A2 (detection limits), CLSI EP25 Ed.2 (reagent stability), and CLSI EP28-A3c (reference intervals). EMC and safety compliance was verified against IEC 61326-2-6:2020, IEC 61326-1:2020, and FCC Part 15 standards.

Substantial equivalence is demonstrated through comparable performance data: precision ranged from 1.4–3.1% CV, linearity covered the analytical range with R² >0.96 for all analytes, and method comparison against the Roche Cobas analyzer showed strong correlation (R ≥0.964). Technological characteristics, specimen types, detection methods, and indications for use are functionally equivalent to the predicate devices (Medicon Hellas and Abaxis Piccolo).