(71 days)
Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
Lyphochek Coagulation Control is prepared from human plasma with added constituents of non-human origin and purified biochemicals. The control is provided in lyophilized form for increased stability.
The provided text is a 510(k) summary for a medical device called "Lyphochek Coagulation Control." This document describes a quality control product used to monitor the precision of coagulation systems, not a diagnostic or AI-powered device.
Therefore, the information requested in your prompt (such as acceptance criteria, details of a study on device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable to this type of document or device.
The document focuses on demonstrating substantial equivalence to a predicate device based on intended use, form, matrix, storage, open vial stability, and assay claims, which are typical for a quality control product submission.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.