FDA product code PKQ: Computerized Cognitive Assessment Aid
PKQ is the FDA product code for computerized cognitive assessment aid. It is a Class II device, regulated under 21 CFR 882.1470 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under PKQ, from 2 different applicants. The average 510(k) review took 232 days (median 232). 1 De Novo request was granted under it.
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
Classification
| Field | Value |
|---|---|
| Device name | Computerized Cognitive Assessment Aid |
| Device class | Class II |
| Regulation | 21 CFR 882.1470 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for PKQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 246 |
Compare with all 510(k) review times · Search every PKQ clearance
Top PKQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. | 1 | 2017-01-13 |
| Vista Lifesciences, Inc. | 1 | 2015-08-28 |
Most recent PKQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161328 | Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. | Cantab Mobile | 2017-01-13 | 246 |
| K150154 | Vista Lifesciences, Inc. | ANAM Test System: Military Battery | 2015-08-28 | 217 |
Recalls for PKQ devices
openFDA lists no recalls for product code PKQ.
Frequently asked questions
What is FDA product code PKQ?
PKQ is the FDA product code for computerized cognitive assessment aid. It is a Class II device, regulated under 21 CFR 882.1470 and reviewed by the Neurology panel.
What device class is PKQ?
Class II, regulation 21 CFR 882.1470. Typical premarket route: 510(k).
How long does a 510(k) take for product code PKQ?
Across 2 cleared submissions the average was 232 days from receipt to decision (median 232).
Which companies have the most PKQ clearances?
Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. (1); Vista Lifesciences, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PKQ
- Run a recall and safety report across every PKQ manufacturer
- Watch product code PKQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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