# K231433: The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Aug 31, 2023 after 106 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Rezafungin in the dilution range of 0.008 - 8 ug/mL for testing Candida spp. on the Sensititre YeastOne Susceptibility System. Rezafungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida parapsilosis.

Source page: https://510kreport.com/device/K231433
Methodology: https://510kreport.com/methodology