Athelas Home

The Athelas Home device is intended for adult patients at risk of neutropenia to quantitatively measure white blood cell counts and neutrophil percentages from capillary whole blood in a home setting, with results transmitted directly to healthcare professionals. It employs a microfluidic test strip to prepare a stained monolayer of cells, which are then imaged and analyzed using computer vision algorithms for automated cell counting and classification.

The Athelas Home is an in vitro diagnostic system for the quantitative determination of white blood cell (WBC) counts and neutrophil percentages (NEUT%) from a capillary whole blood sample. Designed for prescription use by adult patients (21 years and older) at risk of neutropenia, or their caregivers, in a home environment, it utilizes Athelas Home Test Strips. The device's methodology involves a microfluidic test strip channel that creates a stained monolayer of white blood cells using pre-loaded Cresyl Violet and Methylene Blue. Multiple images of this monolayer are then captured and analyzed by computer vision-based image analysis to count and classify the cells. Results are transmitted securely to healthcare professionals for interpretation and are not intended as the sole basis for patient diagnosis or management. The Athelas Home is technologically identical to the Athelas One device in terms of core technology, analytes, components, and usage process, but features additional software and quality control safeguards, including remote lockout capabilities, specifically for safe and effective at-home operation. The performance of the Athelas Home was established through comprehensive testing, including bench, clinical, at-home, and flex studies, with some data leveraged from the identical Athelas One device as the core technologies are the same. Bench testing confirmed within-run and between-run precision, reproducibility, linearity, limits of detection and quantification, and absence of interference from various substances. Specimen and test strip stability were also established. At-home studies specifically validated the device’s precision when used by laypersons, its usability, and low error rates (over 94% success). Clinical method comparison against laboratory analyzers and the Athelas One confirmed its accuracy. Extensive flex testing demonstrated the device's robustness against variable sample fill volumes, device tilting, drops, extreme temperatures, vibration, and humidity, with test strip integrity protected by specialized packaging.

AI Regulatory Concerns

Powered by

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

• Q1. How does the device's performance (precision, bias) specifically at critical low neutrophil levels (e.g., below 0.5 K/µL or severe neutropenia thresholds) compare to traditional laboratory methods in real-world home use scenarios over extended periods?; What are the specific software and quality control safeguards implemented in the Athelas Home that differ from the Athelas One to ensure safe and effective at-home use by laypersons, particularly concerning error detection and user guidance?; Given that results are transmitted to healthcare providers, what is the typical turnaround time for clinician review and patient notification, and what mechanisms are in place for urgent result alerts for critical values?; The document mentions patients with psychiatric conditions require clinical judgment for self-testing; what specific usability or cognitive challenges were identified during development, and are there any adaptive features or specialized training protocols recommended for these patient populations?; Beyond WBC and NEUT%, what is the potential for this microfluidic and computer vision platform to be expanded for other hematological parameters or cell types suitable for monitoring in a home-use setting?