# K232963: VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jun 7, 2024 after 260 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: 4 generations back to K092454 (2010). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
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.

Source page: https://510kreport.com/device/K232963
Methodology: https://510kreport.com/methodology