FDA 510K for Trichomonas Vaginalis Nucleic Acid Amplification Test System
A Trichomonas vaginalis nucleic acid amplification test (NAAT) is a laboratory test that detects the presence of this sexually transmitted infection (STI). The test is more sensitive than culture-based methods.
Intended Use of Trichomonas Vaginalis Nucleic Acid Amplification Test System
A Trichomonas vaginalis nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of Trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of trichomoniasis in asymptomatic women. The detection of Trichomonas nucleic acids, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of trichomoniasis caused by Trichomonas vaginalis.
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 Trichomonas Vaginalis Nucleic Acid Amplification Test System
FDA 510K for Trichomonas Vaginalis Nucleic Acid Amplification Test System Device Code and Regulation Number
| Sl .no | Product code | Device | Regulation Description | Regulation Number | Class |
| 1 | OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | Trichomonas Vaginalis Nucleic Acid Assay | 866.3860 | 2 |
Trichomonas Vaginalis Nucleic Acid Amplification Test System
Intended use:
It is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis
Device Description:
The Trichomonas Vaginalis Nucleic Acid Amplification Test (NAAT) is a highly sensitive and specific diagnostic method used to detect Trichomonas vaginalis, the parasite responsible for trichomoniasis, a common sexually transmitted infection. By amplifying the genetic material of the parasite in patient samples, such as vaginal swabs, urine, or penile discharge, NAAT provides faster and more reliable results compared to traditional methods like microscopy or culture. It is particularly useful for detecting asymptomatic infections, which are common in many individuals. With its ability to accurately identify low-level infections and provide quick results, NAAT has become the preferred choice for routine screening and diagnosis of trichomoniasis in clinical settings.
Performance Testing (Analytical) for Trichomonas Vaginalis Nucleic Acid Amplification Test System
- Accuracy
- Precision (Reproducibility and Repeatability)
- Linearity
- Traceability
- Sensitivity and Specificity
- Limit of Detection (LoD), Limit of Quantitation (LoQ), and Limit of Blank (LoB)
Clinical Testing
No Guidance available for 510k submission