EarliPoint Assessment

K253442

Earlitec Diagnostics · cleared 2026-03-05 · product code QPF · Neurology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Software analyzes the eye-tracking data and provides a diagnosis for ASD. In addition, it also outputs 3 developmental delay indices (called EarliPoint Severity Indices) that proxy validated ASD instruments”
AlgorithmSoftware analyzes the eye-tracking data and provides a diagnosis for ASD. In addition, it also outputs 3 developmental delay indices (called EarliPoint Severity Indices) that proxy validated ASD instruments
source quote (p.6)
“Software analyzes the eye-tracking data and provides a diagnosis for ASD. In addition, it also outputs 3 developmental delay indices (called EarliPoint Severity Indices) that proxy validated ASD instruments”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Prospective clinical

n=1,064 patients

endpoints: sensitivity; specificity; correlation with ADOS-2; correlation with Mullen/DAS-II

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

Reported performance (5 observations)

sensitivity80.2CI 75.6%, 84.3%
source quote (p.11)
“80.2% (272/339) 95% CI: 75.6%, 84.3%”
specificity81.3CI 76.7%, 85.3%
source quote (p.11)
“81.3% (274/337) 95% CI: 76.7%, 85.3%”
ppvas written: “Positive Predictive Value”81.2CI 76.6-85.2
source quote (p.9)
“81.2% (76.6-85.2)”
npvas written: “Negative Predictive Value”80.4CI 75.7-84.4
source quote (p.9)
“80.4% (75.7 - 84.4)”
accuracyas written: “Accuracy”80.8CI 77.6-83.7
source quote (p.9)
“80.8% (77.6 - 83.7)”

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
0
drift signals on this device

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/K253442