Cleared Traditional

K150154 - ANAM Test System: Military Battery (FDA 510(k) Clearance)

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

K150154 · Vista Lifesciences, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Aug 2015
Decision
217d
Days
Class 2
Risk

K150154 is an FDA 510(k) clearance for the ANAM Test System: Military Battery. Classified as Computerized Cognitive Assessment Aid (product code PKQ), Class II - Special Controls.

Submitted by Vista Lifesciences, Inc. (Parker, US). The FDA issued a Cleared decision on August 28, 2015 after a review of 217 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 Vista Lifesciences, Inc. devices

Submission Details

510(k) Number K150154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2015
Decision Date August 28, 2015
Days to Decision 217 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 148d · This submission: 217d
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.