FDA 510k for Dengue Virus Serological Reagents
Dengue virus serological reagents are diagnostic devices that detect anti-dengue antibodies in individuals exhibiting dengue fever or dengue haemorrhagic fever. These reagents consist of antigens and antisera.
Intended Use of Dengue Virus Serological Reagents
Dengue virus serological reagents are devices that consist of antigens and antibodies for the detection of dengue virus and dengue antibodies in individuals who have signs and symptoms of dengue fever or dengue haemorrhagic fever. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue haemorrhagic fever caused by dengue virus.
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 Dengue Virus Serological Reagents
Dengue Virus Serological Reagents Device Code and Regulation Number
| # | Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | QCU | Dengue Virus Antigen Assay | Dengue virus serological reagents | 866.3945 | 2 |
Dengue Virus Antigen Assay (QCU)
Test method: The DENV Detect NS1 ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum. This test is for the presumptive clinical laboratory diagnosis of Dengue virus infection. This assay is intended for use in patients with clinical symptoms consistent with either dengue fever or dengue haemorrhagic fever. Samples collected from patients within seven (7) days after the onset of clinical symptoms should be evaluated with this assay (day 0 – day 7). Negative results obtained with this test do not preclude the diagnosis of dengue and should not be used as the sole basis for treatment or other patient management decision.
Device description: The DENV Detect NS1 ELISA is a two-step immunoassay used to detect low levels of NS1 in serum. It involves diluted controls and unknown samples in a dilution buffer containing secondary antibody, incubated in microtitration wells coated with a highly effective NS1 antibody, and “sandwiched” between the capture and secondary antibodies. The presence of NS1 antigen is confirmed by a colorimetric response using an antibody-HRP conjugate and liquid 3, 3′, 5, 5′-tetramethylbenzidine (TMB) substrate. The enzymatic turnover of the substrate is determined by absorbance measurement at 450 nanometres. The kit contains enough reagents for one plate of 96 wells.
Performance Testing (Analytical)
- Stability Studies
- Precision/Reproducibility
- Detection studies
- Linearity/assay reportable range
- Analytical specificity
- Assy cut off
The same is applicable for CE Marking under IVDR also.
Clinical Testing
No Guidance available for 510k submission and IVDR CE Marking