# K232967: VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jun 12, 2024 after 265 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
Longest line of descent: 3 generations back to K092454 (2010). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, bioMerieux, Inc. (2022) Summary page 4.

## Indications for use
VITEK 2 AST-Yeast Voriconazole 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 Voriconazole is a quantitative test. Voriconazole 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 krusei Candida parapsilosis Candida tropicalis 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.

Source page: https://510kreport.com/device/K232967
Methodology: https://510kreport.com/methodology