510(k) DEN040003
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 21, 2004
- Date Received
- March 22, 2004
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Invasive Fungal Pathogens
- Device Class
- Class II
- Regulation Number
- 866.3050
- Review Panel
- MI
- Submission Type
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.