21 CFR 866.2952 — Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Microbiology (MI) · De Novo Classifications · § 866.2952

Identification

OMNIgene.GUT Dx is a device 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 the device. The device consists of a collection tube with a tube top and pusher cap with a screw seal, a spatula or spoon for transferring fecal specimen, 2 mL of stabilizing liquid, and a stainless-steel mixing ball. It is designed to preserve the relative abundances of bacterial organisms in fecal specimens stored at room temperature (20-26°C) for up to 30 days.

Classification Rationale

Class II (special controls). The device is classified under 21 CFR 866.2952 as a device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples.

Product Codes