# DEN160033: ARK Voriconazole II Assay Test System

- Pathway: De Novo (Direct)
- Applicant: Ark Diagnostics, Inc.
- Decided: May 5, 2017 after 294 days
- Product code: PUJ (Voriconazole Test System)
- Device class: 2
- Regulation: 21 CFR 862.3970
- 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
ARK Voriconazole II Assay Test System includes separately provided test kits for the ARK Voriconazole II Assay, ARK Voriconazole II Calibrator, and ARK Voriconazole II Control. The ARK Voriconazole II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of voriconazole in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of voriconazole to help ensure appropriate therapy. The assay should only be used in conjunction with information available from clinical evaluations and other diagnostic procedures. ARK Voriconazole II Calibrator is intended for use in calibration of the ARK Voriconazole II Assay. ARK Voriconazole II Control is an assayed quality control material intended for use in quality control of the ARK Voriconazole II Assay.

Source page: https://510kreport.com/device/DEN160033
Methodology: https://510kreport.com/methodology