510(k) Report

510(k) · Cleared

Cleared

Vitek 2 Yeast Voriconazole

K092454510(k) TraditionalCleared May 21, 2010284-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 May 21, 2010 after a 284-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.

Decided
May 21, 2010
Review
284 days
Class
Class II
Product code
NGZ
Recalls
None
Predicates
0

9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 2 descendants cleared2022: 2 descendants cleared2016: 2 descendants cleared2018: 1 descendant cleared2024: 2 descendants clearedReference device: K050002 · Vitek 2 Compact · bioMerieux, Inc. · 2005 · recalled2010201520202025
  1. This deviceK092454 Vitek 2 Yeast VoriconazolebioMerieux, Inc. · 2010
  2. Descendant · cites it directly · 5 of its ownK133952 Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast FlucytosinebioMerieux, Inc. · 2014
  3. Descendant · 2 generations on · 2 of its ownK151817 VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLbioMerieux, Inc. · 2016
  4. Descendant · cites it directly · 2 of its ownK133817 Vitek 2 Ast - Yeast FluconazolebioMerieux, Inc. · 2014
  5. Descendant · 3 generations on · 1 of its ownK213899 VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS…bioMerieux, Inc. · 2022
  6. Descendant · 2 generations on · 1 of its ownK213241 VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS…bioMerieux, Inc. · 2022

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2014: 22016: 22018: 12022: 22024: 2
2014high 2 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 9 · See all
  • K133952Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast FlucytosinebioMerieux, Inc. · 2014 · cites it directly5descendants
  • K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLbioMerieux, Inc. · 2016 · 2 generations on2descendants
  • K133817Vitek 2 Ast - Yeast FluconazolebioMerieux, Inc. · 2014 · cites it directly2descendants
  • K213899VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125…bioMerieux, Inc. · 2022 · 3 generations on1descendant
  • K213241VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64…bioMerieux, Inc. · 2022 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K092454Vitek 2 Yeast VoriconazolebioMerieux, Inc.2010—
+1K133952Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast FlucytosinebioMerieux, Inc.2014—
+2K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLbioMerieux, Inc.2016—
+1K133817Vitek 2 Ast - Yeast FluconazolebioMerieux, Inc.2014—
+3K213899VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS…bioMerieux, Inc.2022—
+2K213241VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole…bioMerieux, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201620
201810
202220
202420
FIG. 1 — Lineage of K092454, 2010–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232963 VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >=…score 8.4 · 4 generations · no Class I recall
  2. #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.

TypeNumberDeviceApplicantDecidedRecalls
*—VITEK 2 Yeast Fluconazole
Named without a submission number
—
†K050002Vitek 2 CompactbioMerieux, Inc.20056

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133952Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast FlucytosinebioMerieux, Inc.20145
K133817Vitek 2 Ast - Yeast FluconazolebioMerieux, Inc.20142

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, K133952 (bioMerieux, Inc., 2014) has gone furthest, with 5 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. 2010, this device’s year, is highlighted.

FDA decisions per year · NGZ

1in 2025

2009: 32010: 22014: 32016: 22018: 12021: 12023: 32024: 22025: 1
2007high 3 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NGZ

204in 2023

2009: 326 days median2014: 232 days median2023: 204 days median
2007high 326 (2009) · low 204 (2023)2026

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

Recalls per year · NGZ

2in 2022

2022: 2
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

2011: 12014: 12015: 12016: 92017: 162018: 102021: 82022: 32023: 32024: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
2009332600
20102—00
20110—01
20120—00
20130—00
2014323201
20150—01
20162—09
20170—016
20181—010
20190—00
20200—00
20211—08
20220—23
2023320403
20242—01
20251—00
20260—0—

What is it indicated for?

VITEK® 2 Yeast Voriconazole is designed for antifungal susceptibility testing of Candida species. VITEK 2 Yeast Voriconazole is a quantitative test intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. Voriconazole has been shown to be active against most strains of the following microorganisms listed below according to the FDA label for the antifungal.…

Read the full statement (147 words)

VITEK® 2 Yeast Voriconazole is designed for antifungal susceptibility testing of Candida species.

VITEK 2 Yeast Voriconazole is a quantitative test intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. Voriconazole has been shown to be active against most strains of the following microorganisms listed below according to the FDA label for the antifungal.

Active in vitro and in clinical infections

Candida albicans

Candida krusei

Candida parapsilosis

Candida tropicalis

Active in vitro but their clinical significance is unknown:

Candida lusitaniae

Candida guilliermondii

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.

More from bioMerieux, Inc.

281 FDA decisions under this applicant name. See the company

  • K260283VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)bioMerieux, Inc. · 2026
  • K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc. · 2026
  • K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026
  • K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025
  • K234012Vitek Compact ProbioMerieux, Inc. · 2025

Recent decisions in NGZ

The NGZ category page

  • K243738The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mLThermo Fisher Scientific · 2025
  • K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)bioMerieux, Inc. · 2024
  • K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)bioMerieux, Inc. · 2024
  • K231433The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mLThermo Fisher Scientific · 2023
  • K221198Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mLThermo Fisher Scientific · 2023

https://510kreport.com/device/K092454 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092454: Vitek 2 Yeast Voriconazole.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092454

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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