Complement C3b Inactivator Immunological Test System

A “Complement C3b inactivator immunological test system” refers to a laboratory method used to measure the level of a specific protein in the blood called “C3b inactivator,” which plays a crucial role in regulating the complement system, a part of the immune system that helps destroy pathogens; this test system utilizes immunological techniques like antibody-antigen interactions to quantify the C3b inactivator concentration in a serum sample.

Function of C3b inactivator: This protein acts as a “brake” on the complement cascade, preventing excessive activation by breaking down a key complement component called C3b, which is essential for opsonization (marking pathogens for destruction by immune cells).

Importance of testing: Measuring C3b inactivator levels can be important in diagnosing certain immune disorders, as a deficiency in this protein can lead to uncontrolled complement activation, potentially causing tissue damage and inflammation

A complement C_3b inactivator immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C_3b inactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C_3b inactivator aids in the diagnosis of inherited antibody dysfunction.

Device description: In the complement system, a C3b activator triggers the cleavage of complement component C3 into its active form, C3b, which then binds to pathogen surfaces, marking them for destruction by immune cells. Activators can include pathogen molecules, antibody-antigen complexes (classical pathway), or molecules like properdin (alternative pathway). An antigen is a molecule that an antibody recognizes and binds to, initiating an immune response and potentially activating the classical complement pathway. Antiserum contains antibodies specific to a particular antigen, such as C3b, and is used in assays to detect C3b. A control is a sample used to ensure assay accuracy, often lacking any added antigen or activator to confirm the absence of unintended C3b activation. C3b functions as an opsonin, aiding in pathogen clearance by immune cells, and is generated through the cleavage of C3, which can occur via the classical, lectin, or alternative complement pathways. C3b is tightly regulated to prevent excessive immune responses.

Device Description: The System is a surgical mesh kit designed for transvaginal treatment to correct anterior and posterior vaginal wall prolapse. It includes instrumentation for transvaginal placement, a monofilament polypropylene mesh, anchors, handles, and passers. The mesh has six fixation points: two posterior fixation points, two middle arms, and two anterior arms. These points can be adjusted by the surgeon to ensure the mesh is flat at the correct tension, preventing wrinkles. The kit includes two anchors with sutures, two anchoring handles, and four passers for placement through the obturator foramens.

• Sensitivity
•  Specificity
• Reproducibility
• Assay Range
• Throughput and Efficiency

The same is also applicable for CE Marking under IVDR.

Required for 510k and IVDR CE Marking submissions.