De Novo · Granted
GrantedGeneSTAT.MDx Coccidioides Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dxna, LLC · QAA Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
Granted on Nov 29, 2017 as a new device type through De Novo after a 120-day review.
- Decided
- Nov 29, 2017
- Review
- 120 days
- Class
- Class II
- Product code
- QAA
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 QAA? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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 QAA devicesQAA Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · QAA
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · QAA
Too few QAA 510(k)s in any year since 2007 to give a median.
Recalls per year · QAA
No recall names QAA since 2007.
Adverse event reports per year · QAA
No MAUDE report names QAA since 2007.
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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GeneSTAT.MDx Coccidioides Assay is a qualitative real-time polymerase chain reaction (PCR) in vitro diagnostic test for the detection of nucleic acids from Coccidioides immitis and Coccidioides posadasii. The assay does not differentiate between these two species. The assay is performed on bronchial alveolar lavage (BAL) or bronchial wash (BW) specimens from patients presenting with respiratory signs and symptoms consistent with coccidioidomycosis.…
Read the full statement (100 words)
The GeneSTAT.MDx Coccidioides Assay is a qualitative real-time polymerase chain reaction (PCR) in vitro diagnostic test for the detection of nucleic acids from Coccidioides immitis and Coccidioides posadasii. The assay does not differentiate between these two species. The assay is performed on bronchial alveolar lavage (BAL) or bronchial wash (BW) specimens from patients presenting with respiratory signs and symptoms consistent with coccidioidomycosis. The GeneSTAT.MDx Coccidioides Assay is intended to be used along with clinical findings and other laboratory results as an aid in the diagnosis of coccidioidomycosis in patients with possible or probable exposure to Coccidioides immitis or Coccidioides posadasii.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170041 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170041: GeneSTAT.MDx Coccidioides Assay.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170041
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026