# K991810: Modification to Sensititre Yeastone Mic Susceptibility Test

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Oct 9, 2001 after 866 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K061945: Vitek 2 Ast-YS Fluconazole (2006), 1 descendant of its own
- K101566: Vitek 2 Yeast Caspofungin (2010), 0 descendants of its own

## Indications for use
The Sensititre® YeastOne™ MIC Susceptibility plate is an ir vitro diagnostic product for determining the clinical susceptibility of Candida species. This 510(k) is for this MIC only panel, the antifungal agents at concentrations listed as follows: Antifungal Agent Dilution Range Fluconazole 0.125 - 256 Itraconazole 0.008-16 S-Flucytosine 0.03 - 64 Organisms with indications for testing include non-fastidious yeast isolates of Candida species.

Source page: https://510kreport.com/device/K991810
Methodology: https://510kreport.com/methodology