(258 days)
The N-Assay TIA C3 Test Kit is intended to be used for the quantitation of C3 in human serum by immunoturbidimetric assay. The measurement of C3 aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "N-Assay TIA C3 Test Kit." This type of document primarily confirms that a new medical device is substantially equivalent to a previously marketed device (predicate device) and can therefore be marketed.
It describes the intended use of the device: "The N-Assay TIA C3 Test Kit is intended to be used for the quantitation of C3 in human serum by immunoturbidimetric assay. The measurement of C3 aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components."
However, this document does not contain any information regarding acceptance criteria, study details, reported device performance, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the 510(k) submission itself, not in the FDA's clearance letter. The letter only states that the device has been reviewed and found substantially equivalent.
Therefore, I cannot populate the requested table and answer the questions 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).