(91 days)
CASCADE™ Liquid Coagulation Control, Levels 1, 2, and 3 is a human plasma based quality control material intended for use in the clinical laboratory as a consistent tool of known concentration for monitoring the performance of coagulation assays (prothrombin time, activated partial thromboplastin time, and fibrinogen assays). The user can compare recovered values with expected ranges and is a means of assuring consistent performance of for use on the MLA 1600 analyzer.
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This document is a marketing clearance letter from the FDA for a medical device called "CASCADE™ Liquid Coagulation Control, Levels 1, 2, and 3". It does not contain information about the device's acceptance criteria, performance studies, or related details that would typically be found in a clinical study report or a 510(k) summary.
Therefore, I cannot provide the requested information. The document primarily focuses on the regulatory approval and classification of the device.
§ 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.