Tru Hematology Test

The Tru Hematology Test is an in vitro diagnostic device part of the TruWellness Panel that measures complete blood count (CBC) parameters including WBC, RBC, hemoglobin, hematocrit, platelets, and a 3-part white blood cell differential (neutrophils, lymphocytes, and other WBCs) from lithium-heparinized venous whole blood samples. It is intended for use in clinical laboratory and point-of-care settings for adults 18 years and older, and is not intended for diagnosing or monitoring critical disease states such as oncology.

The Tru Hematology Test uses computer vision-based blood analysis with brightfield and fluorescence microscopy for most parameters, with hemoglobin measured by cyanmethemoglobin photometric method and hematocrit by microhematocrit centrifugation. Key differences from the Sight OLO predicate include: specimen type (venous whole blood versus whole blood capillary), anticoagulant (lithium heparin versus K2-EDTA), measurement of only 14 analytes versus 20 in the predicate, and different assay principles for hemoglobin and hematocrit.

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), CLSI H20-A2 (WBC differential), and IEC/ETSI/FCC standards for electromagnetic compatibility and safety.

Substantial equivalence is demonstrated through performance testing showing the device produces acceptable results compared to the predicate Sight OLO (K190898) across key performance characteristics: precision with CV values generally under 10%, linear performance across the claimed measuring ranges, detection limits established below the limit of quantitation, and method comparison showing strong correlation (R values 0.826–0.996) with the FDA-cleared Sysmex XN comparator analyzer. The device is in the same product code and regulatory class as the predicate and has similar intended use in clinical laboratory and point-of-care settings.