# K133952: Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast Flucytosine

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Aug 19, 2014 after 239 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.
5 later devices descend from it; 2 cite it directly.
0 of 7 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
- K151817: VITEK 2  AST-YS Caspofungin <=0.125 - >=8 ug/mL (2016), 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
- K151923: VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) (2016), 1 descendant of its own
- K232963: VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (2024), 0 descendants of its own
- K181368: VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) (2018), 0 descendants of its own

## Indications for use
VITEK® 2 Yeast Flucytosine is designed for antimicrobial susceptibility testing of clinically significant yeast 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 antimicrobial agents. VITEK® 2 Yeast Flucytosine is a quantitative test. Flucytosine 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 The following in vitro data are available, but their clinical significance is unknown. Candida dubliniensis Candida glabrata Candida guilliermondii Candida lusitaniae Candida parapsilosis Candida tropicalis 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/K133952
Methodology: https://510kreport.com/methodology