# K092784: C. Albicans/C. Glabrata Pna Fish

- Pathway: 510(k) (Traditional)
- Applicant: Advandx, Inc.
- Decided: Mar 12, 2010 after 183 days
- Product code: NZS (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast)
- Device class: 1
- Regulation: 21 CFR 866.2660
- 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
C. albicans/C. glabrata PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of C. albicans and/or C. glabrata on smears made from yeast positive blood cultures. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. C. albicans/C. glabrata PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. glabrata fungemia.

Source page: https://510kreport.com/device/K092784
Methodology: https://510kreport.com/methodology