510(k) · Cleared
ClearedEtest Voriconazole 0.002-32 UG/ML
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ab Biomerieux · NGZ Susceptibility Test Plate, Antifungal
Cleared on Nov 2, 2009 after a 426-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 2, 2009
- Review
- 426 days
- Class
- Class II
- Product code
- NGZ
- Recalls
- None
- 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)
No FDA recall names this device.
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. 2009, this device’s year, is highlighted.
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?
This submission is for Etest®Voriconazole for MIC determinations across 0.002-32 gLg/mL with C. albicans, C. glabrata, C. krusei, C. parapilosisand C. tropica/is.
Etest® is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in gLg/mL inhibiting the growth of the test organism under defined conditions.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K082534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082534: Etest Voriconazole 0.002-32 UG/ML.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082534
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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