Athelas One

K181288

Athelas Inc. · cleared 2018-11-05 · product code GKZ · Hematology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“A microfluidic test strip channel creates a stained monolayer of white blood cells. Multiple images are taken of the monolayer and the cells are counted and classified by computer vision based image analysis. Internet connected device for processing results on cloud server.”
Algorithmcomputer vision based image analysis
source quote (p.5)
“Multiple images are taken of the monolayer and the cells are counted and classified by computer vision based image analysis.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“As per the cybersecurity suggestions, the device should be connected to the internet either via a wired ethernet connection or a protected WPA 802.11n network. The network of the PoC setting should be placed behind a firewall that strictly regulates access to only those services that need it.”

Validation studies (13)

Bench

n=810 other

Bench

n=240 other · 3 site(s)

Bench

n=10 cases

endpoints: linearity

standards: CLSI EP6-A, CLSI EP06-A

Bench

sample size not stated

endpoints: interference impact on bias and precision performance

Standalone

n=120 other

endpoints: reference interval verification

Bench

n=120 other

endpoints: Limit of Blank

Bench

n=120 other

endpoints: Limit of Detection

Bench

n=4 cases

endpoints: lowest measurement concentration

Bench

n=9 cases

endpoints: stability duration

standards: CLSI EP25-A

Bench

sample size not stated

endpoints: shelf life stability

standards: CLSI EP25-A

Retrospective clinical

n=312 patients · 3 site(s)

endpoints: performance comparison (slope, r, bias at medical decision levels, overall bias, bland altman analysis, intercept)

Retrospective clinical

n=312 patients

endpoints: flagging accuracy

Retrospective clinical

n=59 patients

endpoints: regression parameters; 95% confidence interval of bias at the medical decision levels

standards: CLSI EP5-A3, H26-A2

Reported performance (2 observations)

sensitivity90.91
source quote (p.15)
“% Positive Agreement (Sensitivity) = 100 * 90/(90 + 9) = 90.91%”
specificity96.71
source quote (p.15)
“% Negative Agreement (Specificity) = 100 * 206/(206 + 7) = 96.71%”

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/K181288