# DEN170041: GeneSTAT.MDx Coccidioides Assay

- Pathway: De Novo (Direct)
- Applicant: Dxna, LLC
- Decided: Nov 29, 2017 after 120 days
- Product code: QAA (Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens)
- Device class: 2
- Regulation: 21 CFR 866.3376
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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.

Source page: https://510kreport.com/device/DEN170041
Methodology: https://510kreport.com/methodology