# K101566: Vitek 2 Yeast Caspofungin

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Sep 28, 2010 after 116 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 K991810 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061945: Vitek 2 Ast-YS Fluconazole, bioMerieux, Inc. (2006)

## Indications for use
VITEK® 2 Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species. VITEK 2 Yeast Caspofungin 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. Caspofungin has been shown to be active both in vitro and in clinical infections against most strains of the following microorganisms according to the FDA label for the antifungal. Candida albicans Candida krusei Candida glabrata Gandida parapsilosis Candida guillierrnondii 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 spop., Enterococcus spp., Streptococcus agalactiae, S.pneumoniae and clinically significant yeast.

Source page: https://510kreport.com/device/K101566
Methodology: https://510kreport.com/methodology