PKQ · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1470
Classification
FDA Product Code
PKQ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.1470
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The computerized cognitive assessment aid provides clinicians in a healthcare setting with objective measurements of cognitive function as a screening aid in the assessment of adults 55 years of age and older. This is done for the purpose of identifying a potential decline in cognitive function relative to baseline test performance of other age-normal adults, referring those adults for further testing where warranted, and monitoring changes in cognitive function over time