(182 days)
The AggRaM Analyzer is a 4-channel aggregometer designed to perform platelet aggregation and Ristocetin cofactor testing on patients for hemostasis abnormalities. Platelet aggregation studies are performed to quantitate platelet response and identify abnormal platelet function. The agonist, Ristocetin, can be used in the diagnosis of von Willebrand's disease. "Nibeoous" reagents are used to quantitate the von Willebrand factor activity.
AggRAM Analyzer
The provided text is a 510(k) clearance letter for the HemoRam/AggRAM Analyzer System and its indications for use. It does not contain information about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth methodologies.
Therefore, I cannot extract the requested information from the provided document. The document primarily focuses on the regulatory clearance of the device based on its substantial equivalence to previously marketed devices.
§ 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.