# DEN200040: OMNIgene GUT Dx

- Pathway: De Novo (Direct)
- Applicant: DNA Genotek, Inc.
- Decided: Nov 3, 2021 after 506 days
- Product code: QPO (Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples)
- Device class: 2
- Regulation: 21 CFR 866.2952
- 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
OMNIgene•GUT Dx is intended for the non-invasive collection of human fecal samples and the stabilization of DNA from the bacterial community for subsequent assessment of the microbiome profile by an assay validated for use with OMNIgene•GUT Dx.

Source page: https://510kreport.com/device/DEN200040
Methodology: https://510kreport.com/methodology