# K061945: Vitek 2 Ast-YS Fluconazole

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Sep 19, 2006 after 71 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 K991810 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991810: Modification to Sensititre Yeastone Mic Susceptibility Test, Trek Diagnostic Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K101566: Vitek 2 Yeast Caspofungin (2010), 0 descendants of its own

## Indications for use
VITEK® 2 Yeast Fluconazole is designed for antifungal susceptibility testing of Candida species. VITEK 2 Yeast Fluconazole is a quantitative test. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. 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/K061945
Methodology: https://510kreport.com/methodology