EarliPoint System

K213882

EarliTec Diagnostics, Inc. · cleared 2022-06-08 · product code QPF · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“EarliPoint Device with eye-tracking capability captures the patient visual response to social information provided in the form of a series of age-appropriate videos Artificial intelligence software analyzes the eye-tracking data and provides a diagnosis for ASD.”
AlgorithmArtificial intelligence software analyzes eye-tracking data to provide a diagnosis for ASD.
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
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

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

Standalone

sample size not stated

Reported performance (2 observations)

sensitivity0.71CI 64.6% - 76.9%
source quote (p.8)
“EarliPoint (mITD) N=475 71% (157/221) 64.6% - 76.9%”
specificity0.807CI 75.3% - 85.4%
source quote (p.8)
“EarliPoint (mITD) N=475 80.7% (205/254) 75.3% - 85.4%”

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
3
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243891 (decision 2025-03-26) from EarliTec Diagnostics for a matching device line ("EarliPoint System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243891

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K230337 (decision 2023-06-29) from EarliTec Diagnostics, Inc for a matching device line ("EarliPoint") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K230337

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/K213882