Not Cleared Direct

DEN150030 - KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (FDA 510(k) Clearance)

Class II Immunology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN150030 · Kronus, Inc. · Immunology device
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Apr 2016
Decision
298d
Days
Class 2
Risk

DEN150030 is an FDA 510(k) submission (not cleared) for the KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay. Classified as Aquaporin-4 Autoantibody (product code PNI), Class II - Special Controls.

Submitted by Kronus, Inc. (Star, US). The FDA issued a Not Cleared (DENG) decision on April 25, 2016 after a review of 298 days.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5665 - the FDA immunology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 298 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Kronus, Inc. devices

Submission Details

510(k) Number DEN150030 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 02, 2015
Decision Date April 25, 2016
Days to Decision 298 days
Submission Type Direct
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 104d · This submission: 298d
Pathway characteristics

Device Classification

Product Code PNI Aquaporin-4 Autoantibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5665
Definition For The Determination Of Autoantibodies To Aquaporin-4 In Human Serum And Plasma. The Test May Be Useful As An Aid In The Diagnosis Of Neuromyelitis Optica (nmo) And Neuromyelitis Optica Spectrum Disorders (nmosd). The Test Is Not To Be Used Alone And Is To Be Used In Conjunction With Other Clinical And Radiological (mri) Laboratory Findings.
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 Immunology devices follow this clearance model.