EarliPoint System

K243891

EarliTec Diagnostics · cleared 2025-03-26 · product code QPF · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The EarliPoint system uses an eye tracker to capture the patient's looking behavior while viewing a series of videos. The system then remotely analyzes the looking behavior data using software and outputs a diagnosis of the patient's ASD status and associated developmental delay indicies. Artificial intelligence software analyzes the eye-tracking data and provides a diagnosis for ASD.”
AlgorithmArtificial intelligence software
source quote (p.5)
“Artificial intelligence software analyzes the eye-tracking data and provides a diagnosis for ASD.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Prospective clinical

n=500 patients · 6 site(s)

endpoints: evaluate the sensitivity and specificity of the EarliPoint System diagnosis relative to the expert clinical diagnosis; correlated the three EarliPoint Severity Indices of social disability, verbal ability and nonverbal ability against the corresponding expert clinical instruments of ADOS-2 and Mullen

standards: IEC 62304, IEC 60601-1, IEC 60601-1-2

Reported performance (4 observations)

sensitivity71CI 64.6% - 76.9%
source quote (p.7)
“71% (157/221) 64.6% - 76.9%”
specificity80.7CI 75.3%- 85.4%
source quote (p.7)
“80.7% (205/254) 75.3%- 85.4%”
sensitivityas written: “Sensitivity (Clinicians are Certain of Diagnosis only)”78CI 70.5%, 84.3%
source quote (p.7)
“78.0% (117/150) 70.5%, 84.3%”
specificityas written: “Specificity (Clinicians are Certain of Diagnosis only)”85.4CI 79.5% - 90.2%
source quote (p.7)
“85.4% (158/185) 79.5% - 90.2%”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253442 (decision 2026-03-05) from Earlitec Diagnostics for a matching device line ("EarliPoint Assessment") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253442

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 Neurology 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/K243891