Regulatory information

FDA clearance & indications for use.

DANA is an FDA-cleared mobile cognitive assessment platform. This page explains what that clearance covers, and where to verify it directly in the FDA's own public records.

What "FDA-cleared" means

A 510(k) clearance, not an approval.

DANA has received 510(k) clearance from the U.S. Food and Drug Administration. A 510(k) clearance means the FDA has reviewed the device and determined it is substantially equivalent to a legally marketed predicate device — a different regulatory pathway than "FDA approval," which is why DANA's materials use the term "FDA-cleared," not "FDA-approved."

  • Clearance covers a specific, defined set of indications for use — the device is only marketed for those cleared uses, for individuals ages 8 and up.
  • DANA is not a diagnostic tool. Results should be interpreted only by qualified professionals.
  • In 2024, DANA passed a post-clearance FDA inspection covering current software and cybersecurity expectations with no action indicated — the highest rating.
  • Clearance status can be independently verified in the FDA's public database (below).
Clearance details
  • 510(k) number: K141865
  • Device classification name: Recorder, Attention Task Performance
  • Product code: LQD
  • Predicate device: QbTest (K122149), Qbtech AB
  • Clearance letter date: October 15, 2014
  • Type of use: Prescription Use (21 CFR 801 Subpart D)
Cleared indications for use

The exact wording from DANA's 510(k) clearance.

DANA provides clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual's medical or psychological state. Factors that may affect the measurement of reaction time include, but are not limited to concussion, head injury, insomnia, post-traumatic stress disorder (PTSD), depression, attention deficit hyperactivity disorder (ADHD), memory impairment, dementia, delirium, prescription and non-prescription medication, some nutritional supplements, as well as a variety of psychological states (e.g., fatigue and stress).

DANA also delivers and scores standardized psychological questionnaires. DANA results should be interpreted only by qualified professionals.

Quoted directly from FDA Form 3881 (Indications for Use) filed with 510(k) K141865. DANA is not a diagnostic tool; this list describes factors that can affect reaction-time measurement, not conditions DANA diagnoses.

Verify independently

Look up the clearance yourself.

FDA 510(k) clearances are public record. Search the FDA's own database rather than relying on marketing claims alone.

FDA 510(k) Premarket Notification Database

Search by applicant name (AnthroTronix, Inc.) or product code to find the clearance record directly on FDA.gov.

Search the FDA database
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