Cleared Special

K161951 - KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (FDA 510(k) Clearance)

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

K161951 · Kronus, Inc. · Immunology device
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Jul 2016
Decision
7d
Days
Class 2
Risk

K161951 is an FDA 510(k) clearance 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 Cleared decision on July 22, 2016 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5665 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kronus, Inc. devices

Submission Details

510(k) Number K161951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2016
Decision Date July 22, 2016
Days to Decision 7 days
Submission Type Special
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 104d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

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.