(204 days)
This kit is intended for the quantitative in vitro determination of human C3c in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings.
Not Found
The provided text is related to a 510(k) premarket notification for a medical device called "Human C3c Kit for use on SPAPLUSTM". It grants substantial equivalence to legally marketed predicate devices, but it does not contain a detailed study report with acceptance criteria, performance data, or information about sample sizes, ground truth establishment, or expert involvement as requested.
The document is an FDA clearance letter and an "Indications for Use" statement. It does not describe a performance study in the way a scientific paper or a detailed clinical trial report would.
Therefore, I cannot fulfill your request for detailed information regarding acceptance criteria and a study proving the device meets those criteria based only on the provided text. The text confirms the device's intended use and regulatory status but does not describe the specific performance study that led to its clearance.
§ 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).