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510(k) Data Aggregation
K Number
DEN200040Device Name
OMNIgene GUT Dx
Manufacturer
DNA Genotek Inc.
Date Cleared
2021-11-03
(506 days)
Product Code
QPO
Regulation Number
866.2952Why did this record match?
Product Code :
QPO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The OMNIgene . GUT Dx device consists of a collection tube with a tube top and pusher cap with a screw seal, along with a spatula or spoon for transferring fecal specimen into the collection tube. The tube contains 2 mL of the stabilizing liquid and a stainless-steel mixing ball. These components are intended to stabilize bacterial DNA in human fecal specimens. notably to preserve the relative abundances of bacterial organisms, for potential downstream analysis of the fecal microbiome. The collection device is designed for storage of fecal specimens at room temperature (20-26°C/68-79°F) for up to 30 days.
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