# K060099: S. Aureus Pna Fish

- Pathway: 510(k) (Traditional)
- Applicant: Advandx, Inc.
- Decided: May 8, 2006 after 115 days
- Product code: NXX (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus)
- Device class: 1
- Regulation: 21 CFR 866.3700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K090964: Binaxnox Staphylococcus Aureus Test (2009), 0 descendants of its own

## Indications for use
S. aureus PNA FISH is a qualitative nucleic acid hybridization assay intended for presumptive identification of Staphylococcus aureus from blood cultures.

Source page: https://510kreport.com/device/K060099
Methodology: https://510kreport.com/methodology