Fungal Organisms, Nucleic Acid-Based Assay
The Fungal Organisms Nucleic Acid-Based Assay is a qualitative multiplexed in vitro diagnostic device designed to detect and identify fungal organisms in positive blood cultures, enabling rapid diagnosis of invasive fungal infections such as candidemia. It falls under the Microbiology medical specialty and is classified as a Class 2 device under regulation 866.3365, requiring 510(k) premarket notification. Early identification of fungal pathogens is critical for initiating appropriate antifungal therapy in critically ill patients. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PEO
- Device Class
- FDA class 2
- Regulation Number
- 866.3365
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240627 | LIAISON PLEX Yeast Blood Culture Assay | Jun 04, 2024 | Substantially Equivalent | Luminex Corporation |
| K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel | Dec 21, 2018 | Substantially Equivalent | Genmark Diagnostics, Incorporated |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.