# K200828: Athelas Home

- Pathway: 510(k) (Traditional)
- Applicant: Athelas, Inc.
- Decided: Mar 22, 2022 after 722 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K040073 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181288: Athelas One, Athelas, Inc. (2018) Summary page 5.

## Most influential descendants
- K243348: Athelas Home (2026), 0 descendants of its own

## Indications for use
The Athelas Home is indicated for the quantitative determination of white blood cells (WBC) and Neutrophil percentages (NEUT%) in capillary whole blood. The Athelas Home system is for In Vitro Diagnostic use and for prescription use only. The Athelas Home is only to be used with Athelas Home Test Strips. The Athelas Home is indicated for use by patients and caregivers within home settings with results viewable by health care professionals. The Athelas Home is intended for patients at risk of neutropenia. For patients with psychiatric conditions, clinical judgement should be exercised when deciding the end-user, based on the instructions for use (IFU) of Athelas Home, the treating physician should determine which patients are competent to perform the test by themselves. The Athelas Home is indicated for adult populations only (aged 21 and older). Results obtained with the Athelas Home should not be the sole basis for patient diagnosis, treatment or management of leukopenia and neutropenia. All results should be evaluated by a healthcare provider. The Athelas Home is intended to be used by a single person and should not be shared.

Source page: https://510kreport.com/device/K200828
Methodology: https://510kreport.com/methodology