Cleared Traditional

K161328 - Cantab Mobile (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161328 · Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. · Neurology device
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Jan 2017
Decision
246d
Days
Class 2
Risk

K161328 is an FDA 510(k) clearance for the Cantab Mobile. Classified as Computerized Cognitive Assessment Aid (product code PKQ), Class II - Special Controls.

Submitted by Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. (Bottisham, GB). The FDA issued a Cleared decision on January 13, 2017 after a review of 246 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1470 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. devices

Submission Details

510(k) Number K161328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2016
Decision Date January 13, 2017
Days to Decision 246 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 148d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PKQ Computerized Cognitive Assessment Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1470
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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.