510(k) · Cleared
Recalled · Class II · 2022Etest for Antifungal Suscepttibility Testing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ab Biodisk · NGZ Susceptibility Test Plate, Antifungal
Cleared on Jul 27, 2004 after a 146-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Jul 27, 2004
- Review
- 146 days
- Class
- Class II
- Product code
- NGZ
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NGZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NGZ device
- #1 K232963 VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >=…score 8.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|---|
| Nov 9, 2022 | Class II | Z-0824-2023 | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NGZ devicesNGZ Susceptibility Test Plate, Antifungal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NGZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGZ
204in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGZ
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGZ
1in 2024
MAUDE reports naming product code NGZ, not matched to any one device; reports are not rates.
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 | 3 | 326 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 232 | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 8 |
| 2022 | 0 | — | 2 | 3 |
| 2023 | 3 | 204 | 0 | 3 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Etest® is an agar-based gradient technique for quantitative antifungal susceptibility testing of Card/in species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MiQ in /g/mL inhibiting the growth of the test organism under defined conditions.
This 510k submission is for an application for in zimo diagnostic use of Etest for MIC determination of fluconazole, itraconazole and flucytosine with Cand/"aspecies.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040560 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040560: Etest for Antifungal Suscepttibility Testing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040560
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026