# K133038: Sensititre Yeastone Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems
- Decided: Jan 31, 2014 after 127 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 SensititreS YeastOne4@ Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Micafungin in the dilution range of 0.008 -15 gg/l is intended for testing Candida spp. on the Sensititreo YeastOneP Susceptibility system. The approved primary "Indications for Use" and clinical significance of Micafuingin Is for: Candida albicans Candia glabrata Candida krusei Candida parapsilos/s Can dida tropicalis

Source page: https://510kreport.com/device/K133038
Methodology: https://510kreport.com/methodology