# DEN150030: KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

- Pathway: De Novo (Direct)
- Applicant: Kronus, Inc.
- Decided: Apr 25, 2016 after 298 days
- Product code: PNI (Aquaporin-4 Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Aquaporin-4 in human serum. The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is not to be used alone and is to be used in conjunction with other clinical, laboratory, and radiological (e.g., MRI) findings.

Source page: https://510kreport.com/device/DEN150030
Methodology: https://510kreport.com/methodology