# K151817: VITEK 2  AST-YS Caspofungin <=0.125 - >=8 ug/mL

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 18, 2016 after 227 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: 2 generations back to K092454 (2010). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133952: Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast Flucytosine, bioMerieux, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K232963: VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (2024), 0 descendants of its own

## Indications for use
VITEK® 2 AST-YS Caspofungin 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 antimicrobial agents. VITEK® 2 Yeast Caspofungin is a quantitative test. Caspofungin 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 clinical infections: Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis 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 spp., S. pneumoniae, and clinically significant yeast.

Source page: https://510kreport.com/device/K151817
Methodology: https://510kreport.com/methodology