NQZ · Antigen, Invasive Fungal Pathogens
Microbiology · 21 CFR 866.3050 · Class 2
Overview
| Product Code | NQZ |
|---|---|
| Device Name | Antigen, Invasive Fungal Pathogens |
| Regulation | 21 CFR 866.3050 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Beta-glucan serological assays are devices that consist of antigens or proteases used in serological assays. The device is intended for use for the presumptive diagnosis of fungal infection. 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.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan.” See § 866.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan.” See § 866.1(e) for the availability of this guidance document.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191167 | Fungitell STAT | Associates of Cape Cod, Inc. | Jul 17, 2019 | SESE |
| DEN040003 | GLUCATELL | Associates of Cape Cod, Inc. | May 21, 2004 | DENG |
Top Applicants
- Associates of Cape Cod, Inc. — 2 clearances
