510(k) · Cleared
ClearedModification to Sensititre Yeastone Mic Susceptibility Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trek Diagnostic Systems, Inc. · NGZ Susceptibility Test Plate, Antifungal
Cleared on Oct 9, 2001 after an 866-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Oct 9, 2001
- Review
- 866 days
- Class
- Class II
- Product code
- NGZ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK991810 Modification to Sensititre Yeastone Mic Susceptibility TestTrek Diagnostic Systems, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK061945 Vitek 2 Ast-YS FluconazolebioMerieux, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK101566 Vitek 2 Yeast CaspofunginbioMerieux, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991810 | Modification to Sensititre Yeastone Mic Susceptibility Test | Trek Diagnostic Systems, Inc. | 2001 | — |
| +1 | K061945 | Vitek 2 Ast-YS Fluconazole | bioMerieux, Inc. | 2006 | — |
| +2 | K101566 | Vitek 2 Yeast Caspofungin | bioMerieux, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061945 | Vitek 2 Ast-YS Fluconazole | 2006 | 1 |
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.
What does this lineage say?
- Of its descendants, K061945 (bioMerieux, Inc., 2006) has gone furthest, with 1 descendant of its own.
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?
The Sensititre® YeastOne™ MIC Susceptibility plate is an ir vitro diagnostic product for determining the clinical susceptibility of Candida species.
This 510(k) is for this MIC only panel, the antifungal agents at concentrations listed as follows:
Antifungal Agent Dilution Range
Fluconazole 0.125 - 256
Itraconazole 0.008-16
S-Flucytosine 0.03 - 64
Organisms with indications for testing include non-fastidious yeast isolates of Candida species.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991810: Modification to Sensititre Yeastone Mic Susceptibility Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991810
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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