FDA 510K for Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
A Vaginitis and Bacterial Vaginosis Nucleic Acid Detection System is an in vitro diagnostic device used to detect nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis in clinical samples. This system helps in the rapid identification of pathogens, offering accurate results to aid in diagnosing conditions like bacterial vaginosis, vulvovaginal candidiasis, and vaginitis.
Intended Use of Vaginitis and Bacterial Vaginosis Nucleic Acid Detection System
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.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
FDA 510K for Device Code and Regulation Number
| Sr.
No. |
Product
Code |
Device | Regulation
Number |
Device Class |
|
1 |
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System |
866.3975 |
2 |
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Intended Use
It is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis, Candida species linked to vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in symptomatic patients. It is intended to aid in diagnosing vaginal infections in women presenting with clinical symptoms of bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis.
Device Description
The in vitro device detects nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis using reagents, instrumentation, and automated real-time PCR. It includes disposable cartridges, master mixes, and extraction reagents, with sample preparation steps like DNA extraction, amplification, and detection. System is a qualitative nucleic acid detection system that identifies the presence of specific microbial DNA and/or RNA sequences associated with vaginitis and bacterial vaginosis.
Performance Testing (Analytical) for Vaginitis and Bacterial Vaginosis Nucleic Acid Detection System
- Precision (Repeatability and Reproducibility)
- Accuracy
- Limit of Detection
- Analytical Reactivity (Inclusivity)
- Analytical Specificity (Exclusivity)
- Cross Reactivity
- Software Validation and Verification
- Stability Testing
Clinical Testing; Required for 510k submission.