# K133817: Vitek 2 Ast - Yeast Fluconazole

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Aug 5, 2014 after 232 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: 1 generation back to K092454 (2010). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092454: Vitek 2 Yeast Voriconazole, bioMerieux, Inc. (2010) Summary page 5.

## Most influential descendants
- 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
- K232967: VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (2024), 0 descendants of its own

## Indications for use
VITEK® 2 Yeast Fluconazole is designed for antifungal susceptibility testing of Candida species and 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. VITEK® 2 Yeast Fluconazole has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections Candida albicans Candida parapsilosis Candida tropicalis The following in vitro data are available, but their clinical significance is unknown. Candida dubliniensis Candida guilliermondii Candida lusitaniae The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems 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 spp. and clinically significant yeast.

Source page: https://510kreport.com/device/K133817
Methodology: https://510kreport.com/methodology