510(k) · Cleared
Recalled · 2010EK/P. Aeruginosa Pna Fish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advandx, Inc. · JSS Kit, Identification, Enterobacteriaceae
Cleared on Sep 1, 2009 after a 27-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Sep 1, 2009
- Review
- 27 days
- Class
- Class I
- Product code
- JSS
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JSS? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 8, 2010 | Not classified | Z-0491-2011 | Device Design | Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK /P. aeruginosa PNA FISH to produce a false positive red signal |
No ancestor or descendant has a Class I recall.
How does its category compare?
All JSS devicesJSS Kit, Identification, Enterobacteriaceae: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JSS
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · JSS
228in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JSS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JSS
1in 2023
MAUDE reports naming product code JSS, 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 | 1 | — | 0 | 0 |
| 2009 | 4 | 228 | 0 | 0 |
| 2010 | 1 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 3 | 0 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 1 | 9 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made from positive blood cultures containing Gram-negative rods. The test does not distinguish between E. co/i and K. pneumoniae. Further testing is needed to differentiate E. co/i and K. pneumoniae.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
The EK/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. co/i and/or K. pneumoniae and P. aeruginosa bacteremia.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092393 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092393: EK/P. Aeruginosa Pna Fish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092393
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026