The FDA has a device type that appears to fit this kind of product: "recorder, attention task performance," product code LQD. The classification database still lists it as unclassified (pre-amendment). Computerized attention tests have been cleared under it through the 510(k) pathway since at least 2004. 510(k) is our planned pathway for the ADHD battery, with a cleared device of this type as the predicate. Before submitting, we plan an FDA pre-submission meeting to confirm the device type, the predicate, and the data FDA expects. Our device would not measure motor activity, so its indications may be narrower than those of camera-based predicates. Clearance isn't guaranteed, and timing depends on our validation data. The cognitive-decline battery may follow a different pathway. We'll decide that with regulatory counsel.
SourcesFDA Product Classification database, product code LQD · FDA 510(k) K040894 (2004)