(114 days)
This assay is designed for the in-vitro measurement of circulating immune complexes (CIC) that bind Clq, measurement on on serum. It is intended for the determination of presence in names patients with various autoimmune and other CICrelated disease, and is used in conjunction with other clinical findings.
Not Found
This FDA document is a 510(k) clearance letter for the BINDAZYME C1q Binding Circulating Immune Complex Enzyme Immunoassay Kit. It does not contain information about acceptance criteria or a study that proves the device meets those criteria.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It notes the "Indications for Use" but does not detail performance metrics, study designs, or ground truth establishment.
Therefore, I cannot provide the requested information based on the provided text.
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).