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Server software counts and classifies white cells by computer vision and sends the results to the patient's healthcare provider. Patients do not see the results. In an at-home study, 61 patients at risk of neutropenia or their caregivers ran the tests over 1 to 4 visits. They included patients on clozapine and on immunosuppressive cancer therapy. Trained operators made triplicate measurements on the predicate Athelas One. FDA reviewers report correlations of 0.97 for white-cell count and 0.95 for neutrophil percentage across 117 paired results, with slopes of 1.00. Over 94% of tests ran without errors. FDA cleared the device on 22 March 2022. Caregivers ran 22 of the 32 first-visit tests that were surveyed. The summary does not say whether the image algorithm learned from data.","replication":{"produced_by":["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."],"must_hold":["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."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":28,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":26,"review_not_assessed":63,"not_assessed":0,"complete":false,"by_state":{"value_present":28,"not_reported":0,"unresolved":63,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"6d539028ce2993e07849b44830490d3df85cf8eafc475f7e8aa49926a13e7317"}