Voriconazole Test System
The Voriconazole Test System is a clinical toxicology device intended to measure voriconazole concentrations in human serum, used to monitor drug levels in patients receiving voriconazole therapy for serious fungal infections such as aspergillosis or candidiasis, ensuring therapeutic efficacy and avoiding toxicity. It is classified as FDA Class II under regulation 21 CFR 862.3970, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PUJ and it falls under the Clinical Toxicology medical specialty. It is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- PUJ
- Device Class
- FDA class 2
- Regulation Number
- 862.3970
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Definition
A voriconazole test system is a device intended to measure voriconazole in human serum. Measurements obtained by this device are used in monitoring levels of voriconazole to ensure appropriate therapy.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN160033 | ARK Voriconazole II Assay Test System | May 05, 2017 | Unknown | Ark Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.