510(k) Report

510(k) · Cleared

Cleared

VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

K232963510(k) TraditionalCleared Jun 7, 2024260-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 Jun 7, 2024 as substantially equivalent to K213899 (bioMerieux, Inc., 2022) after a 260-day review. Its family tree reaches back 4 generations to 2010.

Decided
Jun 7, 2024
Review
260 days
Class
Class II
Product code
NGZ
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K092454 (2010). No later device cites it as a predicate yet.

K092454 · Vitek 2 Yeast Voriconazole · bioMerieux, Inc. · 2010K133952 · Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast Flucytosine · bioMerieux, Inc. · 2014K151817 · VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL · bioMerieux, Inc. · 2016K213899 · VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin · bioMerieux, Inc. · 20222010201520202025
K213899 · VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin · bioMerieux, Inc. · 2022K151817 · VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL · bioMerieux, Inc. · 2016K133952 · Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast Flucytosine · bioMerieux, Inc. · 2014K092454 · Vitek 2 Yeast Voriconazole · bioMerieux, Inc. · 20100
  1. Root · 4 generations backK092454 Vitek 2 Yeast VoriconazolebioMerieux, Inc. · 2010
  2. 3 generations backK133952 Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast FlucytosinebioMerieux, Inc. · 2014
  3. 2 generations backK151817 VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLbioMerieux, Inc. · 2016
  4. 1 generation backK213899 VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS…bioMerieux, Inc. · 2022
  5. This deviceK232963 VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)bioMerieux, Inc. · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K092454Vitek 2 Yeast VoriconazolebioMerieux, Inc.2010—
−3K133952Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast FlucytosinebioMerieux, Inc.2014—
−2K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLbioMerieux, Inc.2016—
−1K213899VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS…bioMerieux, Inc.2022—
0 (this device)K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)bioMerieux, Inc.2024—
FIG. 1 — Lineage of K232963, 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 K232967 VITEK 2 AST-Yeast Voriconazole (<= 0.03125 -…score 8.1 · 3 generations · no Class I recall
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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
*K213899VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125…
Summary page 4
…T, LTW, LON Common Name: VITEK® 2 AST-YS Anidulafungin C. Predicate Device: VITEK® 2 AST-Yeast Caspofungin (K213899) D. Device Description: The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration…
bioMerieux, Inc.2022—

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.

What does this lineage say?

  • The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 4.2 years on median.
  • None of the 4 ancestors has a recall.

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. 2024, 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 AST-Yeast Anidulafungin is designed for antifungal susceptibility testing of Candida species and is 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. VITEK 2 AST-Yeast Anidulafungin is a quantitative test. Anidulafungin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this…

Read the full statement (139 words)

VITEK 2 AST-Yeast Anidulafungin is designed for antifungal susceptibility testing of Candida species and is 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. VITEK 2 AST-Yeast Anidulafungin is a quantitative test. Anidulafungin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal.

Active in vitro and in clinical infections:

Candida albicans

Candida glabrata

Candida parapsilosis

Candida tropicalis

In vitro data are available, but clinical significance is unknown:

Candida guilliermondii

Candida krusei

The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.

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
  • 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
  • K221899The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/mlThermo Fisher Scientific · 2023

https://510kreport.com/device/K232963 · printed Nov 4, 2026

Cite this page

510(k) Report. “K232963: VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232963

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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