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U.S. Department of Health and Human Services

Product Classification

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Device antigen, invasive fungal pathogens
Regulation Description Beta-glucan serological assays.
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.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNQZ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan
Third Party Review Not Third Party Eligible
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