# K080719: Yeast Traffic Light Pna Fish

- Pathway: 510(k) (Traditional)
- Applicant: Advandx, Inc.
- Decided: Sep 12, 2008 after 183 days
- Product code: JXB (Kit, Identification, 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
Yeast Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Candida albicans and/or Candida parapsilosis, identification of Candida tropicalis and identification of Candida glabrata and/or Candida krusei from positive blood cultures. The test does not distinguish between C. glabrata and C. krusei. The test does not distinguish between C. albicans and C. parapsilosis.

Source page: https://510kreport.com/device/K080719
Methodology: https://510kreport.com/methodology