510(k) DEN200040
DEN200040 is an FDA 510(k) premarket notification submitted by DNA Genotek, Inc. for the device "OMNIgene GUT Dx". The FDA issued a decision of De Novo Granted on November 3, 2021. The device falls under product code QPO (Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples), a Class II device regulated under 21 CFR 866.2952. DNA Genotek, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 3, 2021
- Date Received
- June 15, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
- Device Class
- Class II
- Regulation Number
- 866.2952
- Review Panel
- MI
- Submission Type
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.