De Novo · Granted
GrantedARK Voriconazole II Assay Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ark Diagnostics, Inc. · PUJ Voriconazole Test System
Granted on May 5, 2017 as a new device type through De Novo after a 294-day review.
- Decided
- May 5, 2017
- Review
- 294 days
- Class
- Class II
- Product code
- PUJ
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PUJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All PUJ devicesPUJ Voriconazole Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PUJ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PUJ
Too few PUJ 510(k)s in any year since 2007 to give a median.
Recalls per year · PUJ
No recall names PUJ since 2007.
Adverse event reports per year · PUJ
No MAUDE report names PUJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (122 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN160033 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN160033: ARK Voriconazole II Assay Test System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN160033
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026