DeviceClearance

Product code QPO— Microbiology

OMNIgene GUT Dx

Classification name
Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
Device class
Class 2
Regulation
21 CFR 866.2952
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“A device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples is a device that consists of a container and reagents intended to stabilize microbial nucleic acids for the subsequent assessment of the relative abundance of microbial nucleic acids (i.e., microbiome) in human specimens by an assay validated for use with the device. The device may also be indicated for sample collection. The device is not intended for preserving morphology or viability of microorganisms.”

— U.S. Food and Drug Administration, device classification record for product code QPO under 21 CFR 866.2952, via openFDA

Market context for product code QPO

FDA has cleared 1 device under product code QPO, all in 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QPO

Recent clearances under product code QPO

Data sourced from openFDA. This site is unofficial and independent of the FDA.