Lipids

Lipids is an in vitro diagnostic device part of the TruWellness Panel used on the TruVerus analyzer to quantitatively measure Total Cholesterol and Triglycerides from lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. Very Low-Density Lipoprotein Cholesterol (VLDL) is calculated from the Triglyceride result. It aids physicians in diagnosing and treating lipid disorders and metabolic diseases in adults 18 years and older.

The device uses photometric/colorimetric detection similar to predicates but operates at different wavelengths (TChol: 510 nm; TRIG: 540 nm versus predicate 340/405 nm and 500/850 nm). It measures the same analytes with slightly expanded measuring ranges (TRIG: 20–700 mg/dL versus predicate 20–500 mg/dL) and accepts only lithium-heparinized whole blood specimens compared to predicate devices accepting multiple specimen types. The TruVerus analyzer shares the same benchtop form factor, touchscreen interface, centrifugation-based blood separation, and 37°C assay temperature as predicate devices.

CLSI EP05-A3 (precision), CLSI EP06-Ed2 (linearity), CLSI EP07-Ed3 and EP37-Ed1 (interference testing), CLSI EP09c-Ed3 (method comparison), CLSI EP17-A2 (detection limits), CLSI EP25-Ed2 (reagent stability), IEC 61326-2-6:2020 and IEC 61326-1:2020 (electromagnetic compatibility and safety), and FCC Part 15 (electromagnetic emissions).

Substantial equivalence is demonstrated through performance testing showing the Lipids device meets the same analytical performance characteristics as predicates: acceptable precision (CV% ≤3%), linearity across claimed ranges (20–520 for TChol, 20–700 for TRIG), comparable detection limits, minimal interference from endogenous and exogenous substances, and excellent method correlation (R=0.995 for TChol, R=0.998 for TRIG) versus FDA-cleared comparator methods. The device uses the same photometric detection method and intended use settings, with calibration traceable to NIST and validated reference materials.