Antigen, Invasive Fungal Pathogens
The Invasive Fungal Pathogen Antigen device consists of antigens, antisera, or proteases used in serological assays to aid in the presumptive diagnosis of invasive fungal infections in serum or plasma. It is indicated for use in patients with symptoms of, or medical conditions predisposing them to, invasive fungal infection, and can assist in the diagnosis of deep-seated mycoses and fungemias. The device is FDA Class 2 under 21 CFR 866.3050, requiring 510(k) clearance, and belongs to the Microbiology specialty with product code NQZ. Results should be interpreted in conjunction with other diagnostic procedures such as microbiological culture, histological examination, and radiological imaging. A positive result does not identify the specific class of fungi causing infection.
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Basic Information
- Product Code
- NQZ
- Device Class
- FDA class 2
- Regulation Number
- 866.3050
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
Invasive fungal pathogen assays are devices that consist of antigens, antisera, or proteases used in serological assays for the presumptive diagnosis of fungal infection in serum or plasma. The assay is indicated for use in patients with symptoms of, or medical conditions predisposing the patient to invasive fungal infection. The device can be used as an aid in the diagnosis of deep seated mycoses and fungemias. A positive result does not indicate which class of fungi may be causing infection. The assays should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
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.