Hematology · 510(k) · 2026
Athelas Home
Athelas, Inc.. Cleared by FDA on 6 February 2026 under submission K243348, product code GKZ (counter, differential cell). What FDA's record says, in FDA's words.
Device record · K243348
- Device. Athelas HomeDEVICE
- Company. Athelas, Inc.COMPANY
- Decision. 6 February 2026, 510(k), substantially equivalent (traditional review); received 28 October 2024DECISION
- Panel. HematologyPANEL
- Product code. GKZ, Counter, Differential CellCODE
- Regulation. 21 CFR 864.5220, Class IIREG
- Source. FDA database entry · decision document (30 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Athelas Home is indicated for the quantitative determination of white blood cells (WBC) and Neutrophil percentages (NEUT%) in capillary whole blood from fingerstick for patient self-testing with results viewable by healthcare professionals, and in capillary or K2EDTA venous whole blood for multiple-patient use in point-of-care settings. For self- testing, the Athelas Home is intended to be used by a single person and should not be shared. The Athelas Home is only to be used with Athelas Test Strips. The Athelas Home is intended for adult patients (aged 21 and older) at risk of neutropenia. For self-testing patients with psychiatric conditions, clinical judgment should be exercised when deciding the end-user and based on the instructions for use (IFU), the treating physician should determine which patients are competent to perform the test by themselves. Results obtained with the Athelas Home should not be the sole basis for patient diagnosis, treatment, or management of leukopenia and neutropenia, and all results should be evaluated by a healthcare provider. Prescription Use Only.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsa diagnostic claim
- Mentionsprescription use
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 23,449 reports filed against devices carrying product code GKZ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
18 September 2026 · Malfunction · Alinity hq Analyzer · Abbott Laboratories · report 3016438761-2026-00518
17 September 2026 · Malfunction · Alinity hq Analyzer · Abbott Laboratories · report 3016438761-2026-00516
The customer observed falsely depressed Hemoglobin on the Alinity hq Processing Module for one female patient. The following results were provided:(b)(6) 2026, SID (b)(6), initial Hemoglobin results= 78 g/L, 76 g/L; repeat result on a recollected sample= 84 g/L; result from (b)(6) 2026= 84 g/L (reference range 120 to 160 g/L). There was no impact to patient management reported.
14 September 2026 · Malfunction · Alinity hq Analyzer · Abbott Laboratories · report 3016438761-2026-00504
The customer observed falsely decreased Hemoglobin (Hgb) results on a 52-Year-old male patient on an Alinity hq analyzer. Results were reported and were questioned by the medical provider. The following data was provided:SID (b)(6): Initial results 78.6 g/L(7.86 g/dL), repeat results 78.2 g/L(7.82 g/dL), Repeat results with different sample on Another Alinity hQ analyzer (b)(6) = 84.4 g/L(8.44 g/dL) and 83.9 g/L (8.39 g/dL). There was no impact to patient management reported.
9 September 2026 · Malfunction · Alinity hq Analyzer · Abbott Laboratories · report 3016438761-2026-00495
4 September 2026 · Malfunction · CELL-DYN Ruby · Abbott Laboratories · report 2919069-2026-00008
The customer observed falsely decreased hemoglobin (Hgb) results by the CELL DYN Ruby analyzer for a 82yrs old female patient. The results provided were:On (b)(6)2026 SID (b)(6) Hemoglobin: Initial=6.44 g/dL /repeated=6.31 g/dL.Redrawn and repeated SID (b)(6) =10.1 g/dL.On (b)(6)2026=9.4 g/dL.ON (b)(6)2026=10.2 g/dL.On (b)(6)2026=11.0 g/dL.ON (b)(6)2026=12.3 g/dL.On (b)(6)2026=10.7 g/dL.There was no reported impact to patient management.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code GKZ, in Hematology, from Athelas, Inc., or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
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