# K090964: Binaxnox Staphylococcus Aureus Test

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Dec 16, 2009 after 254 days
- Product code: JWX (Kit, Screening, Staphylococcus Aureus)
- 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
Longest line of descent: 1 generation back to K060099 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060099: S. Aureus Pna Fish, Advandx, Inc. (2006) Summary page 1.

## Indications for use
The BinaxNOW® Staphylococcus aureus Test is a qualitative, in vitro immunochromatographic assay for the presumptive identification of Staphylococcus aureus. The test is performed directly on blood culture samples positive for Gram-positive cocci in clusters. The BinaxNOW® Staphylococcus aureus Test is not intended to diagnose Staphylococcus aureus nor to guide or monitor treatment for Staphylococcus aureus infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.

Source page: https://510kreport.com/device/K090964
Methodology: https://510kreport.com/methodology