Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
QPO · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.2952
Classification
FDA Product Code
QPO
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.2952
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.