Athelas Home

K243348

Athelas, Inc. · cleared 2026-02-06 · product code GKZ · Hematology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.8)
“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.”
Algorithmimage processing algorithm
source quote (p.8)
“The images are automatically transmitted to the cloud server where they are processed and analyzed by an image processing algorithm.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (6)

Bench

n=810 other · 3 site(s)

endpoints: Precision (CV%); Standard Deviation (SD)

standards: CLSI EP05-A3

Standalone

n=24 patients

endpoints: WBC CV%; NEUT% SD; NEUT% CV

standards: CLSI EP05-A3

Retrospective clinical

n=312 patients · 3 site(s)

endpoints: slope; r (correlation coefficient); bias at medical decision levels; overall bias; bland altman analysis; intercept

standards: CLSI EP5-A3, CLSI H26-A2

Retrospective clinical

n=312 cases

endpoints: Flagging accuracy; Positive Agreement (Sensitivity); Negative Agreement (Specificity); Overall Agreement

Retrospective clinical

n=59 patients

endpoints: regression parameters (slope, r, intercept); bias at medical decision levels

standards: CLSI EP5-A3, CLSI H26-A2

Retrospective clinical

n=165 cases

endpoints: slope; r (correlation coefficient); bias at medical decision levels; overall bias; bland altman analysis; intercept

Reported performance (4 observations)

sensitivity90.91
source quote (p.18)
“% Positive Agreement (Sensitivity) = 100 * 90/(90 + 9) = 90.91%”
specificity96.71
source quote (p.18)
“% Negative Agreement (Specificity) = 100 * 206/(206 + 7) = 96.71%”
ppvas written: “WBC Precision (Max CV%)”5.96
source quote (p.9)
“CV 5.96% 7.50%”
ppvas written: “NEUT% Precision (Max Within-Run SD)”2.967
source quote (p.11)
“50.823 240 2.967 5.838”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

14
recalls in product code, 24mo
61
MAUDE reports in code, 12mo
-55%
vs code's own 3-yr baseline
2
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code GKZ (Abbott Laboratories, initiated 2025-09-18): "Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97788

  • recall_reason_pattern

    Software/algorithm-related recall in product code GKZ (Abbott Laboratories, initiated 2025-03-18): "When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96567

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Hematology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243348