(173 days)
The CIC-C1q EIA is intended for the quantitative determination of circulating immune complexes (CIC) in serum or plasma.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called "ALPCO Diagnostic's CIC-C1q EIA". This letter grants regulatory approval based on substantial equivalence to a predicate device. It does not contain any information about specific acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or comparative effectiveness studies.
The document states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices". This means the FDA found that the device is as safe and effective as a device already on the market, by relying on the predicate device's established safety and effectiveness.
Therefore, I cannot fulfill your request for the specific details of acceptance criteria and a study proving the device meets them because this information is not present in 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).