# K092454: Vitek 2 Yeast Voriconazole

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: May 21, 2010 after 284 days
- Product code: NGZ (Susceptibility Test Plate, Antifungal)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VITEK 2 Yeast Fluconazole: named in the summary without a submission number

## Most influential descendants
- K133952: Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast Flucytosine (2014), 5 descendants of its own
- K151817: VITEK 2  AST-YS Caspofungin <=0.125 - >=8 ug/mL (2016), 2 descendants of its own
- K133817: Vitek 2 Ast - Yeast Fluconazole (2014), 2 descendants of its own
- 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 (2022), 1 descendant of its own
- K213241: VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (2022), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K092454
Methodology: https://510kreport.com/methodology