Athelas Home

The Athelas Home is an automated white blood cell (WBC) and neutrophil percentage (NEUT%) analyzer for quantitative blood testing. It performs point-of-care testing on capillary fingerstick samples for at-home self-testing by adult patients (age 21+) at risk of neutropenia, and on venous K2EDTA samples for multiple-patient use in clinical settings. Results are transmitted securely to healthcare providers for review; the device is prescription-use only.

The Athelas Home is identical in technology, core software, measured analytes, and usage process to its predicates (Athelas Home K200828 and Athelas One K181288). It uses microfluidic test strips that create a stained monolayer of white blood cells; images are captured by a built-in camera and processed via cloud-based image analysis. The device measures WBC (1–25 K/µL range) and NEUT% using the same reagents (Cresyl Violet and Methylene Blue stain), requires 3.5 µL sample volume, and performs automatic calibration at test start with no manual user calibration required.

Testing followed CLSI guidelines including EP05-A3 (precision/reproducibility), EP06-A (linearity), EP17-A2 (limit of quantification), and EP25-A (stability). Bench testing included within-run and between-run precision studies; clinical testing included method comparison against Sysmex XE-5000 (312 patient samples) and at-home method comparison against Athelas One (165 samples). Flagging comparison followed Sysmex XN series design (FDA 510k K112605). Drop testing followed ASTM 1469-D03. Device cleaning robustness was validated over 10,000 cycles.

The Athelas Home is substantially equivalent to its predicates because it is technologically identical in all material respects—same core software, analytes measured, components, test principle, specimen types (capillary and venous whole blood), and performance specifications. All bench and clinical testing (precision, linearity, method comparison, flagging accuracy, stability) met pre-defined acceptance criteria equivalent to predicate performance. At-home usability and error analysis (94% success rate) confirmed safe use in home settings. The addition of venous blood capability and point-of-care use sites does not change the fundamental technology or performance.