QPO — Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples Class II

FDA Device Classification

Classification Details

Product Code
QPO
Device Class
Class II
Regulation Number
866.2952
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN200040dna genotekOMNIgene GUT DxNovember 3, 2021