Francisella tularensis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Francisella tularensis in serum or to identify Francisella tularensis in cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Francisella tularensis directly from clinical specimens.
Intended Use of Francisella Tularensis Serological Reagents
The identification aids in the diagnosis of tularaemia caused by Francisella tularensis and provides epidemiological information on this disease. Tularaemia is a disease principally of rodents but may be transmitted to humans through the handling of infected animals, animal products, or by the bites of fleas and ticks. The disease takes on several forms depending upon the site of infection, such as skin lesions, lymph node enlargements, or pulmonary infection.
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 Francisella Tularensis Serological Reagents
Francisella Tularensis Serological Reagents Device Code and Regulation Number
| # | Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | OEH | Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit | Francisella tularensis serological reagents | 866.3280 | 2 |
Device Description of Francisella tularensis serological reagents.
The system is composed of a portable instrument, laptop computer and software, and the Detection Kit, which includes specific freeze-dried reagents for the detection of a gene target of the F. tularensis. The Detection Kit is specially designed for performing real-time PCR in glass capillaries using the instrument and software.
Performance Testing (Analytical)
- 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
Data are not available for 510k submission and IVDR CE Marking