# K140619: Meca Xpressfish

- Pathway: 510(k) (Traditional)
- Applicant: Advandx, Inc.
- Decided: Oct 10, 2014 after 213 days
- Product code: MYI (System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K850291 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090301: Binaxnow PBP2A Test, Model 890-000, Binax, Inc. (2010) Summary page 5.

## Indications for use
mecA XpressFISH® is a qualitative nucleic acid fluorescence in situ hybridization assay intended for the detection of mecA mRNA on smears from blood cultures that are positive for Staphylococcus aureus by the Staphylococcus QuickFISH™ BC assay. The mecA XpressFISH® assay is indicated for use in conjunction with other laboratory tests and clinical data available to the clinician as an aid in the detection of mecA mRNA from methicillin-resistant S. aureus (MRSA) from patient positive blood cultures. The mecA XpressFISH® assay is not intended to monitor treatment for MRSA infections or for use with mixed cultures including those containing both S. aureus and coagulase negative staphylococci. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, epidemiological typing, and/or differentiation of mixed growth.

Source page: https://510kreport.com/device/K140619
Methodology: https://510kreport.com/methodology