(400 days)
ThymoStat™ is a qualitative plate ELISA for the detection of human anti-rabbit antibodies in human serum. The presence of human anti-rabbit antibodies has been associated with patients receiving injections of rabbit antibodies for therapeutic purposes.
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This document is primarily a letter from the FDA regarding 510(k) clearance for the ThymoStat™ ELISA device. It confirms FDA approval but does not contain detailed information about acceptance criteria or specific study methodologies, performance data, or ground truth establishment.
Therefore, I cannot provide the requested information from the given text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about the experts for ground truth.
- Adjudication methods.
- Whether MRMC studies were done or effect sizes.
- Stand-alone performance.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
§ 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).