# K082534: Etest Voriconazole 0.002-32 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Ab Biomerieux
- Decided: Nov 2, 2009 after 426 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
This submission is for Etest®Voriconazole for MIC determinations across 0.002-32 gLg/mL with C. albicans, C. glabrata, C. krusei, C. parapilosisand C. tropica/is. Etest® is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in gLg/mL inhibiting the growth of the test organism under defined conditions.

Source page: https://510kreport.com/device/K082534
Methodology: https://510kreport.com/methodology