510(k) · Cleared

Cleared

Vitek 2 Ast-YS Fluconazole

K061945510(k) TraditionalCleared Sep 19, 200671-day reviewClass II21 CFR 866.1640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

bioMerieux, Inc. · NGZ Susceptibility Test Plate, Antifungal

Cleared on Sep 19, 2006 as substantially equivalent to K991810 (Trek Diagnostic Systems, Inc., 2001) after a 71-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Sep 19, 2006
Review: 71 days
Class: Class II
Product code: NGZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K991810 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK991810 Modification to Sensititre Yeastone Mic Susceptibility TestTrek Diagnostic Systems, Inc. · 2001
This deviceK061945 Vitek 2 Ast-YS FluconazolebioMerieux, Inc. · 2006
Descendant · cites it directly · 0 of its ownK101566 Vitek 2 Yeast CaspofunginbioMerieux, Inc. · 2010

Most influential descendants

Showing 1 of 1 · See all

K101566Vitek 2 Yeast CaspofunginbioMerieux, Inc. · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K991810	Modification to Sensititre Yeastone Mic Susceptibility Test	Trek Diagnostic Systems, Inc.	2001	—
0 (this device)	K061945	Vitek 2 Ast-YS Fluconazole	bioMerieux, Inc.	2006	—
+1	K101566	Vitek 2 Yeast Caspofungin	bioMerieux, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K061945, 2001–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K991810	Modification to Sensititre Yeastone Mic Susceptibility Test Summary page 1 …Antimicrobial Susceptibility Test Common Name: VITEK 2 AST-YS Fluconazole C. Predicate Device: YEASTONE®(K0991810) Fluconazole D. 510(k) Summary: VITEe#2 Yeast Fluconazole is designed for antifungal susceptibility testing of Candida…	Trek Diagnostic Systems, Inc.	2001	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101566	Vitek 2 Yeast Caspofungin	bioMerieux, Inc.	2010	0

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?

Its one ancestor has no recall.
Of its descendants, K101566 (bioMerieux, Inc., 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NGZ devices

NGZ Susceptibility Test Plate, Antifungal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NGZ

1in 2025

2007high 3 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NGZ

204in 2023

2007high 326 (2009) · low 204 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NGZ

2in 2022

2007high 2 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NGZ

1in 2024

2007high 16 (2017) · low 0 (2007)2025

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?

VITEK® 2 Yeast Fluconazole is designed for antifungal susceptibility testing of Candida species. VITEK 2 Yeast Fluconazole is a quantitative test. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antifungal agents.

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae,S. pneumoniae and clinically significant yeast.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061945 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061945: Vitek 2 Ast-YS Fluconazole.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061945

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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