Cognoa ASD Diagnosis Aid

DEN200069

Cognoa, Inc. · granted 2021-06-02 · product code QPF · Neurology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.2)
“The Cognoa ASD Diagnosis Aid is a software as a medical device (SaMD) that utilizes a machine-learning algorithm that receives independent information from caregivers or parents, trained analysts, and healthcare professionals (HCPs) to aid in the diagnosis of ASD.”
Algorithmmachine-learning algorithm
source quote (p.2)
“The Cognoa ASD Diagnosis Aid is a software as a medical device (SaMD) that utilizes a machine-learning algorithm that receives independent information from caregivers or parents, trained analysts, and healthcare professionals (HCPs) to aid in the diagnosis of ASD.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.3)
“Regarding the cybersecurity, the documentation included all the recommended information from the FDA guidance document, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” This includes a threat model, cybersecurity mitigation information, an upgrade and maintenance plan, and other information for safeguarding the device algorithms.”

Validation studies (3)

Bench

sample size not stated

standards: FDA's guidance document, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” (May 11, 2005)

Bench

sample size not stated

endpoints: evaluate HCP completion of critical tasks associated with use of the HCP Portal component of the Cognoa ASD Diagnosis Aid

Prospective clinical

n=425 patients · 14 site(s)

endpoints: positive predictive value (PPV); negative predictive value (NPV); proportion of patients for whom the device provides no result; sensitivity; specificity; adverse events (AEs); serious adverse events (SAEs)

standards: DSM-5 criteria

Reported performance (4 observations)

sensitivity0.9844CI 91.6%, 99.96%
source quote (p.7)
“98.44% (63/64) 91.6%, 99.96%”
specificity0.7887CI 67.56%, 87.67%
source quote (p.7)
“78.87% (56/71) 67.56%, 87.67%”
ppvas written: “PPV”0.8077CI 70.27%, 88.82%
source quote (p.7)
“80.77% (63/78) 70.27%, 88.82%”
npvas written: “NPV”0.9825CI 90.61%, 99.96%
source quote (p.7)
“98.25% (56/57) 90.61%, 99.96%”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

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 De Novo 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/DEN200069