510(k) · Cleared
Recalled · Class II · 2022Fungitell STAT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Associates of Cape Cod, Inc. · NQZ Antigen, Invasive Fungal Pathogens
Cleared on Jul 17, 2019 as substantially equivalent to DEN040003 (Associates of Cape Cod, Inc., 2004) after a 77-day review. Its family tree reaches back 1 generation to 2004. It has been recalled once.
- Decided
- Jul 17, 2019
- Review
- 77 days
- Class
- Class II
- Product code
- NQZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN040003 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backDEN040003 GlucatellAssociates of Cape Cod, Inc. · 2004
- This deviceK191167 Fungitell STATAssociates of Cape Cod, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN040003 | Glucatell | Associates of Cape Cod, Inc. | 2004 | — |
| 0 (this device) | K191167 | Fungitell STAT | Associates of Cape Cod, Inc. | 2019 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN040003 | GlucatellSummary page 3…Microbiology (83) 3. PREDICATE DEVICE Proprietary Name: Fungitell® STAT 510(k) Number: DEN040003 Common/Usual Name: Antigen, Invasive Fungal Pathogens Classification Name:… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 17, 2022 | Class II | Z-1774-2022 | Employee error | Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All NQZ devicesNQZ Antigen, Invasive Fungal Pathogens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NQZ
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · NQZ
Too few NQZ 510(k)s in any year since 2007 to give a median.
Recalls per year · NQZ
No recall names NQZ since 2007.
Adverse event reports per year · NQZ
No MAUDE report names NQZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (100 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191167: Fungitell STAT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191167
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026