FDA 510K For John Cunningham Virus Serological Reagents
John Cunningham Virus serological reagents are devices that consist of antigens and antisera used in serological assays to identify antibodies to the John Cunningham Virus in serum and plasma. The assay is intended for the qualitative detection of antibodies to JC virus in human serum or plasma
Intended Use of John Cunningham Virus Serological Reagents
Identification aids in the risk stratification for the development of progressive multifocal leukoencephalopathy in multiple sclerosis and Crohn’s disease patients undergoing natalizumab therapy. These devices are for adjunctive use, in the context of other clinical risk factors for the development of progressive multifocal leukoencephalopathy.
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 John Cunningham Virus Serological Reagents
John Cunningham Virus Serological Reagents Device Code and Regulation Number
| # | Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | OYP | Anti-Jcv Antibody Detection Assay | John Cunningham Virus serological reagents. | 866.3336 | 2 |
Anti-Jcv Antibody Detection Assay
Intended Use: It is intended for the qualitative detection of antibodies to JC virus in human serum or plasma. The assay is intended for use in conjunction with other clinical data, in multiple sclerosis patients receiving or considering natalizumab therapy, as an aid in risk stratification for progressive multifocal leukoencephalopathy development. The assay is for professional use only. The assay is not intended for donor screening. The performance of this assay has not been established for use in other immunocompromised patient populations or patients with different disease conditions or undergoing other treatments or in neonates and pediatric patient populations.
Device Description: It consists of two devices. The first is an initial detection ELISA and the second device is a confirmatory (inhibition) ELISA. Both tests utilize the same recombinant antigen which is used in two different formats. The devices include the following reagents; Recombinant JC virus like particles (VLP), a JCV high and low positive controls, consisting of human sera that is positive for JCV antibodies, and JCV negative control consisting of human sera that is negative for JCV antibodies. The conjugate, substrate, wash buffers, and blocking buffers needed for the test are not supplied with the device and are listed together with other reagents and consumables in the device labeling.
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 for John Cunningham Virus Serological Reagents
No Guidance available for 510k submission and IVDR CE Marking