Athelas Home let patients run white-cell counts at home

In FDA's review of Athelas Home, 61 patients or their caregivers ran finger-prick tests at home. The counts matched trained operators on the predicate device, with a correlation of 0.97.

  • 2 a person

    Patients at risk of neutropenia gained a home test whose counts correlated with trained operators' counts at 0.97 for white cells and 0.95 for neutrophil percentage.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Reported benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

Trained operators testing the same patients on the predicate Athelas One. Measured.

The system’s part
Not isolated. The study compared home testing on Athelas Home with trained operators on the predicate, which uses the same technology. It did not compare monitoring with and without the device. The summary describes computer vision-based image analysis with a locked algorithm and does not say whether it learned from data.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

Download data Cite Suggest a correction

Benefit type
Improved Accessibility
System
Athelas Home
Made by
Athelas, Inc.
Used by
Athelas (at-home study in which 61 patients or their caregivers ran the tests)
Stage
In a pilot
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events, Estimating the Quantifiable Characteristics of Products, Events, or Information
Collections
Scrutiny and findings
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. 510(k) substantial equivalence determination decision summary for Athelas Home (K200828). Cleared 2022-03-22.

    A total of 61 patients (including patients with neutropenia, patients with autoimmune diseases, patients on immunosuppressive oncology therapy and patients on clozapine) were enrolled in the study, 1–4 visits per patient. Patients (untrained operators) were instructed to conduct tests on the Athelas Home following the labeling process.

Details

AI system

Workflow

A finger-prick sample filled a test strip pre-coated with methylene blue and cresyl violet stains. Images were sent to a server and analyzed by a locked image processing algorithm.

Follow-up

Conditions for replication

The user is an adult aged 21 or older at risk of neutropenia, and the treating physician judges whether the patient can run the test. A healthcare provider evaluates every result.

Entry details

Sector

Healthcare.

Purpose

Athelas built Athelas Home so that patients at risk of neutropenia and their caregivers can measure white-cell counts and neutrophil percentages at home, with results sent to a healthcare provider.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). Athelas Home let patients run white-cell counts at home (AIBD-0807). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0807.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

BibTeX Data Field definitions