EarliPoint System

K213882

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

FDA 510(k) summary for EarliPoint System (K213882)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
2
Performance observations
2
Product code
QPF
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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 2026-08-26.

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.

Related FDA clearances

More AI/ML devices under product code QPF

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

EarliPoint Assessment

K253442

Earlitec Diagnostics

cleared 2026-03-05

Canvas Dx

K243558

Cognoa, Inc.

cleared 2025-04-11

EarliPoint System

K243891

EarliTec Diagnostics

cleared 2025-03-26

EarliPoint

K230337

EarliTec Diagnostics, Inc

cleared 2023-06-29

Cognoa ASD Diagnosis Aid

DEN200069

Cognoa, Inc.

cleared 2021-06-02

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K213882