DEN200040 is an FDA 510(k) submission for the OMNIgene GUT Dx. This device is classified as a Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples (Class II - Special Controls, product code QPO).
Submitted by DNA Genotek, Inc. (Ottawa, CA). The FDA issued a Not Cleared (DENG) decision on November 3, 2021.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2952. 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..
| 510(k) Number | DEN200040 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 15, 2020 |
| Decision Date | November 03, 2021 |
| Days to Decision | 506 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | QPO - Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.2952 |
| 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. |