Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
The Device to Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples is a microbiology device consisting of a container and reagents that stabilize microbial nucleic acids to enable subsequent assessment of the relative abundance of microbial nucleic acids (microbiome) in human specimens, and may also be indicated for sample collection. It is not intended for preserving morphology or viability of microorganisms. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 866.2952 in the Microbiology specialty. It carries product code QPO and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QPO
- Device Class
- FDA class 2
- Regulation Number
- 866.2952
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200040 | OMNIgene GUT Dx | Nov 03, 2021 | Unknown | DNA Genotek, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.