Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
The Vaginitis and Bacterial Vaginosis Nucleic Acid Detection System is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis in individuals with signs and symptoms of these infections. It is classified as FDA Class 2 under 21 CFR 866.3975 in the Microbiology specialty, requiring 510(k) premarket notification. The device aids in the diagnosis of vaginal infections. Product code PQA; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PQA
- Device Class
- FDA class 2
- Regulation Number
- 866.3975
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243725 | BD Vaginal Panel | Dec 19, 2024 | Substantially Equivalent | Becton, Dickinson and Company |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay | Nov 25, 2024 | Substantially Equivalent | Hologic, Inc. |
| K231381 | Xpert Xpress MVP; GeneXpert Xpress System | Oct 19, 2023 | Substantially Equivalent | Cepheid |
| K223653 | BD Vaginal Panel | Mar 06, 2023 | Substantially Equivalent | Becton, Dickinson and Company |
| K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Jun 07, 2022 | Substantially Equivalent | Cepheid |
| K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Feb 09, 2022 | Substantially Equivalent | Cepheid |
| K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit | Oct 18, 2021 | Substantially Equivalent | Geneohm Sciences Canada, Inc. (Bd Life Sciences) |
| K191957 | BD MAX Vaginal Panel | Oct 21, 2019 | Substantially Equivalent | Geneohm Sciences Canada, Inc. (Bd Diagnostics) |
| K190452 | Aptima BV Assay | May 23, 2019 | Substantially Equivalent | Hologic, Inc. |
| K190472 | Aptima CV/TV Assay | May 16, 2019 | Substantially Equivalent | Hologic, Inc. |
| DEN160001 | BD MAX Vaginal Panel, BD MAX Instrument | Oct 28, 2016 | Unknown | Geneohm Sciences Canada, Inc. (Bd Diagnostics) |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.