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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. Prescription Use Only.

The Athelas Home is identical to the Athelas One K181288 in its technology, all software, the analytes measured, all components, and usage process. The Athelas Home has additional software and quality control safeguards to enable at-home usage of the device. Additionally, results generated from the Athelas Home are not shown to end-patients, rather are transmitted via the software directly to their healthcare provider. The Athelas Home also has Remote Lockout capabilities, such that a healthcare provider or manufacturer can remotely lock-out a device for safety in usage. 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 clinicians within home and point-of-care settings, with results viewable by health care professionals only. The Athelas Home is indicated for operation by adult populations only (aged 21 and older). The Athelas Home is not indicated to completely replace a patient's monitoring regimen on reference lab systems. Prescribers should continue monitoring patients using traditional lab-based means as deemed necessary and possible. The Athelas Home is not indicated to return results directly to patients. The Athelas Home directly transfers results to a health-care professional for interpretation and analysis. The Athelas Home is not indicated to directly diagnose or assist in disease management. Rather, the Athelas Home should be used to quantify WBC and Neut% only, with all decision making owned by the physician as per standard of care. The Athelas Home uses image processing and microfluidics in order to measure WBC and NEUT% values from whole blood in point-of-care and home settings. For further technological details refer to Athelas One K181288 application.

Athelas One is indicated for use for quantitative determination of white blood cells (WBC) and Neutrophil percentages (NEUT%) in capillary or K2EDTA venous whole blood. The Athelas One system is for In Vitro Diagnostic use only. The Athelas One is only to be used with Athelas One Test Strips. The Athelas One is indicated for use in clinical laboratories and for point of care settings. The Athelas One is only indicated for use in adult populations (aged 21 and older).

The Athelas One is an automated diagnostic device intended to perform tests on whole blood samples collected in K2EDTA or capillary finger stick samples collected directly into the Athelas One test strip. The system is intended to be placed within the Point of Care, and Clinical Laboratory sites. Athelas One returns WBC and Neut% metrics from the blood sample. A clinician places a sample on the Athelas One test strip either directly from finger or via pipette from K2EDTA whole blood tube. The Athelas One test strip stains and creates a monolayer of the blood sample within the chamber. The strip is inserted into the test strip slot of the Athelas One device and the device returns results by conducting image analysis of cells present. Result-viewing and device control are conducted through a companion tablet/mobile application.