# K191167: Fungitell STAT

- Pathway: 510(k) (Traditional)
- Applicant: Associates of Cape Cod, Inc.
- Decided: Jul 17, 2019 after 77 days
- Product code: NQZ (Antigen, Invasive Fungal Pathogens)
- Device class: 2
- Regulation: 21 CFR 866.3050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN040003 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN040003: Glucatell, Associates of Cape Cod, Inc. (2004) Summary page 3.

## Recalls of this device
- Aug 17, 2022 · Class II · Z-1774-2022: Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes

## Indications for use
The Fungitell® STAT assay is a protease zymogen-based colorimetric assay for the qualitative detection of (1→3)-β-D-glucan in the serum of patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1→3)-β-D-glucan, a major cell-wall component of various medically important fungi5, can be used as an aid in the diagnosis of deep-seated mycoses and fungemias6. A positive result does not indicate which genus of fungi may be causing infection. (1→3)-β-D-glucan index values should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.

Source page: https://510kreport.com/device/K191167
Methodology: https://510kreport.com/methodology