FDA 510k for Treponema Pallidum Nontreponemal Test Reagents
Treponema pallidum nontreponemal test reagent is a laboratory device used to detect antibodies against syphilis by utilizing antigens derived from sources not directly associated with the Treponema pallidum bacteria itself, essentially identifying an antibody-like substance called “reagin” produced by the body in response to a syphilis infection, rather than directly detecting the bacteria itself; commonly used as a screening test for syphilis due to its readily available and relatively inexpensive nature, but often requires confirmation with a more specific “treponemal” test to ensure accuracy.
Intended Use of Treponema Pallidum Nontreponemal Test Reagents
Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genus Treponema and provides epidemiological information on syphilis.
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 Treponema Pallidum Nontreponemal Test Reagents
Treponema Pallidum Nontreponemal Test Reagents Device Code and Regulation Number
|
Product Code |
Device |
Regulation Description |
Regulation Number |
Device Class |
| GMQ | Antigens, Nontreponemal, All |
Treponema pallidum nontreponemal test reagents |
866.3820 |
2 |
|
|
Treponema Pallidum Nontreponemal Test Reagents (GMQ)
Intended Use: The ASI Automated RPR (rapid plasma reagin) Test for Syphilis is a qualitative and semiquantitative flocculation test for detecting nontreponemal antibodies in human serum and plasma, aiding in the diagnosis of syphilis, intended for in vitro diagnostic testing only.
Device Description: Components available antigen, buffer solution, stabilizer preservatives indicator particles etc.
In labelling, Clear instructions for use, including detailed steps for sample collection, preparation, incubation, and interpretation of results, warnings, precautions, and proper handling instructions for biological specimens and reagents need to be added.
The nontreponemal test reagents for Treponema pallidum provide a reliable method for screening syphilis in clinical laboratories. These reagents comply with regulatory standards, ensuring accurate and timely results for patient assessment.
Performance Testing (Analytical) for Treponema Pallidum Nontreponemal Test Reagents
- Precision/Reproducibility
- Traceability (controls, calibrators, or method)
- Retrospective Study
- Analytical Sensitivity
- Analytical Specificity (Cross-Reactivity)
- Interfering Substances
- Precision – Intra and Inter-assay
- Prozone effect study
The same is applicable for CE Marking under IVDR also.
Clinical Testing
Clinical Testing is mandatory for 510k submission and IVDR CE Marking