510(k) · Cleared
ClearedYeast Traffic Light Pna Fish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advandx, Inc. · JXB Kit, Identification, Yeast
Cleared on Sep 12, 2008 after a 183-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 12, 2008
- Review
- 183 days
- Class
- Class I
- Product code
- JXB
- Recalls
- None
- 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 JXB? 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JXB devicesJXB Kit, Identification, Yeast: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JXB
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · JXB
Too few JXB 510(k)s in any year since 2007 to give a median.
Recalls per year · JXB
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXB
6in 2025
MAUDE reports naming product code JXB, 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 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 16 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 27 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 1 | 37 |
| 2022 | 0 | — | 2 | 10 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Yeast Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Candida albicans and/or Candida parapsilosis, identification of Candida tropicalis and identification of Candida glabrata and/or Candida krusei from positive blood cultures. The test does not distinguish between C. glabrata and C. krusei. The test does not distinguish between C. albicans and C. parapsilosis.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K080719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080719: Yeast Traffic Light Pna Fish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080719
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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