FDA 510k for Neisseria Spp. Direct Serological Test Reagents
Neisseria spp. direct serological test reagent” is a medical device, typically consisting of specific antibodies (antisera) designed to identify the presence of Neisseria bacteria directly from a clinical specimen, like a bodily fluid, without needing to first culture the bacteria in a laboratory; essentially, it’s a rapid diagnostic tool used to detect Neisseria species through a serological
Intended Use of Neisseria Spp. Direct Serological Test Reagents
Use to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhoea, and also provides epidemiological information on diseases caused by these microorganisms.
The device does not include products for the detection of gonorrhoea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.
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 Neisseria Spp. Direct Serological Test Reagents
Neisseria Spp. Direct Serological Test Reagents Device Code and Regulation Number
|
Product Code |
Device |
Regulation Description |
Regulation Number |
Device Class |
| LSL | DNA-Reagents, Neisseria |
Neisseria spp. direct serological test reagents |
866.3390 |
2 |
|
|
Neisseria spp. direct serological test reagents (LSL)
Intended Use: Use to detect Neisseria gonorrhoeae DNA in various specimens, including urethral swab, vaginal swab, and urine. It is suitable for asymptomatic and symptomatic individuals to aid in diagnosing gonococcal urogenital disease.
Device Description: Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests, System is a table-top instrument that is designed to be fully contained on a standard laboratory bench-top. The system performs automated extraction of nucleic acids from multiple specimen types in addition to amplification and detection of target nucleic acid sequences when utilized with legally marketed in vitro diagnostic assays.
Performance Testing (Analytical) for Neisseria Spp. Direct Serological Test Reagents
- Stability Studies
- Precision/Reproducibility
- Detection studies
- Linearity/assay reportable range
- Detection limit
- Analytical specificity
- 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