Athelas One

The Athelas One is an automated system for quantifying white blood cells and neutrophil percentages in adult whole blood samples at the point of care or in clinical laboratories. It employs a microfluidic test strip to prepare a stained cell monolayer, which is then analyzed using image capture and computer vision algorithms for cell counting and classification.

The Athelas One is an automated diagnostic device designed for the quantitative determination of white blood cells (WBC) and neutrophil percentages (NEUT%) from capillary or K2EDTA venous whole blood. It is intended for in vitro diagnostic use in clinical laboratories and point-of-care settings for adult populations aged 21 and older. The system utilizes a single-use microfluidic test strip where a blood sample is applied, stained (with Cresyl Violet and Methylene Blue), and forms a monolayer of cells. The device then captures multiple images of this monolayer, and employs computer vision-based image analysis to count and classify the cells, with results and device control managed via a companion tablet/mobile application. Extensive bench and clinical testing demonstrated the Athelas One's performance. Bench studies confirmed precision (WBC: 7.5% CV; Neut%: 5% SD or 15% CV), linearity across its reporting range (WBC: 1-25K/μL), and a low limit of detection (0.079 K/μL) and quantification (0.44 K WBC/µL). No interference was observed from a range of tested substances. Specimen stability was established at 24 hours, and test strips demonstrated stability for 98 days. Clinical method comparison against the Sysmex XE-5000, involving 312 patient samples, showed substantial equivalence. The device also achieved high accuracy (over 90%) in flagging abnormal samples for manual review and demonstrated comparable results between venous and capillary blood samples.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific image analysis algorithms are employed by the Athelas One for cell differentiation and counting, and how robust are they against variations in staining or cell morphology not covered in the interference studies?; Beyond the tested interferents, what is the device's performance with samples from patients with rare hematological conditions or those on novel therapeutic agents that might affect cell appearance or properties?; How does the device's performance, particularly its flagging accuracy, vary across different adult age sub-groups (e.g., young adults vs. elderly) or diverse ethnic populations?; What are the long-term stability and performance characteristics of the Athelas One device and its test strips under real-world point-of-care conditions, including intermittent use and varying operator experience levels?; Could the image data captured by the Athelas One be leveraged for additional diagnostic insights beyond WBC and Neutrophil percentages, such as morphological abnormalities or detection of other cell types with software updates?