# K040560: Etest for Antifungal Suscepttibility Testing

- Pathway: 510(k) (Traditional)
- Applicant: Ab Biodisk
- Decided: Jul 27, 2004 after 146 days
- Product code: NGZ (Susceptibility Test Plate, Antifungal)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0824-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
Etest® is an agar-based gradient technique for quantitative antifungal susceptibility testing of Card/in species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MiQ in /g/mL inhibiting the growth of the test organism under defined conditions. This 510k submission is for an application for in zimo diagnostic use of Etest for MIC determination of fluconazole, itraconazole and flucytosine with Cand/"aspecies.

Source page: https://510kreport.com/device/K040560
Methodology: https://510kreport.com/methodology