FDA 510k for Cryptococcus Neoformans Serological Reagents
Cryptococcus neoformans serological reagents are devices that consist of antigens used in serological tests to identify antibodies to Cryptococcus neoformans in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) and are used to identify Cryptococcus neoformans directly from clinical specimens or from cultured isolates derived from clinical specimens.
Intended Use of Cryptococcus Neoformans Serological Reagents
The identification aids in the diagnosis of cryptococcosis and provides epidemiological information on this type of disease. Cryptococcosis infections are found most often as chronic meningitis (inflammation of brain membranes) and, if not treated, are usually fatal.
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 Cryptococcus Neoformans Serological Reagents
Cryptococcus Neoformans Serological Reagents Device Code and Regulation Number
|
Product Code |
Device |
Regulation Description |
Regulation Number |
Device Class |
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | Cryptococcus neoformans serological reagents |
866.3165 |
2 |
|
MDU |
Antigen, Elisa, Cryptococcus |
Antisera, Latex Agglutination, Cryptococcus Neoformans (GMD)
Intended Use: Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus Gattai) in serum and cerebral spinal fluid (CSF).
Device Description: is a dipstick sandwich immunochromatographic assay which detects cryptococcal antigen in cerebral spinal fluid (CSF). The assay consists of CrAg Lateral Flow test strips which have a gold-conjugated antibody and a gold- conjugated, anti-cryptococcal antibody deposited onto a sample membrane and anti-Crypto antibody and control-line capture antibody striped onto a membrane. The kit also includes a specimen diluent.
Antigen, Elisa, Cryptococcus (MDU)
Intended Use: Cryptococcal Antigen enzyme immunoassay (CrAg EIA) is a qualitative or semi-quantitative (titration) test system for the detection of capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebrospinal fluid (CSF)
Device Description: is a direct immunoenzymatic sandwich microplate assay which detects Cryptococcus antigens in serum and CSF. Anti- Cryptococcus antibodies bound to microwell plates are used as capture antibodies, and horseradish peroxidase (HRP)-conjugated anti-Cryptococcus antibodies are used as detection antibodies. The positive control and standard curve material are composed of cryptococcal capsular polysaccharide antigen in a buffered protein solution with a preservative.
Performance Testing (Analytical) for Cryptococcus Neoformans Serological Reagents
- Stability Studies
- Precision/Reproducibility
- Detection studies
- Detection limit
- Analytical specificity
- Traceability (controls, calibrators, or method)
- Retrospective Study
- Analytical Sensitivity
- Assay cut-off.
- 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
- Antisera, Latex Agglutination, Cryptococcus Neoformans (GMD) – Clinical Testing is mandatory for 510k submission and IVDR CE Marking
-
Antigen, Elisa, Cryptococcus (MDU) – Clinical Testing is mandatory for 510k submission and IVDR CE Marking