510(k) · Cleared
ClearedBinaxnox Staphylococcus Aureus Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Binax, Inc. · JWX Kit, Screening, Staphylococcus Aureus
Cleared on Dec 16, 2009 as substantially equivalent to K060099 (Advandx, Inc., 2006) after a 254-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Dec 16, 2009
- Review
- 254 days
- Class
- Class I
- Product code
- JWX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060099 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK060099 S. Aureus Pna FishAdvandx, Inc. · 2006
- This deviceK090964 Binaxnox Staphylococcus Aureus TestBinax, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060099 | S. Aureus Pna Fish | Advandx, Inc. | 2006 | — |
| 0 (this device) | K090964 | Binaxnox Staphylococcus Aureus Test | Binax, Inc. | 2009 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060099 | S. Aureus Pna FishSummary page 1…OW® S. aureus CLASSifICATION NAME Microorganism differentiation and identification device (JWX) (per 21 CFR 866.2660) PREDICATE DEVICE S. aureus PNA FISHWM (AdvanDx) K#060099 DEVICE DESCRIPTION The BinaxNOWO Staphylococcus aureus Test is a rapid immunochromatographic membrane assay that uses highly sen… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All JWX devicesJWX Kit, Screening, Staphylococcus Aureus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JWX
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · JWX
Too few JWX 510(k)s in any year since 2007 to give a median.
Recalls per year · JWX
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWX
2in 2021
MAUDE reports naming product code JWX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 1 | — | 2 | 0 |
| 2010 | 0 | — | 2 | 2 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K090964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090964: Binaxnox Staphylococcus Aureus Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090964
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026