# K081433: EK/P. Aeruginosa Pna Fish

- Pathway: 510(k) (Traditional)
- Applicant: Advandx, Inc.
- Decided: Mar 26, 2009 after 309 days
- Product code: JSS (Kit, Identification, Enterobacteriaceae)
- 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
EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli/Klebsiella pneumoniae and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The test does not distinguish between E. co/l and K. pneumoniae. Further testing is needed to differentiate E. coli and K. pneumoniae. The EK/P. aeruginosa PNA FISH assay is indicated for use in conjunction with positive blood subcultures as an aid in the identification of E. coil/K. pneumoniae, and/or P. aeruginosa.

Source page: https://510kreport.com/device/K081433
Methodology: https://510kreport.com/methodology