(149 days)
The Prothrombin Time (PT) was first described by Quick and is a common method of monitoring oral anticoagulant treatment in patients receiving warfarin and related drugs. The safety and efficacy of oral anticoagulant therapy is dependent on regular and appropriate laboratory monitoring of the PT test which measures the depression of clotting factors II, VII and X. In 1983 the World Health Organization (WHO) described a scheme for PT standardization based on the International Normalized Ratio (INR). The INR is defined as the Prothrombin Ratio (PR) of the patient raised to the power of the International Sensitivity Index (ISI) of the thromboplastin reagent in use such that INR=PR'S!
With the recent proliferation in both commercial thromboplastins and automated coagulation analyzers, the number of PT system combinations has increased significantly. This, in conjunction with the increasing prevalence of the INR reporting system, has resulted in a heightened awareness of variability in test results between laboratories reporting INR's.
CryoCheck INR Validation Set has been designed to enhance the effective monitoring of oral anticoagulant therapy by providing a set of well characterized warfarinized plasmas with system specific INR assigned ranges.
CryoCheck INR Validation Set is indicated for use in monitoring the accuracy and control of oral anticoagulant therapy using the International Normalized Ratio (INR) on a variety of prothrombin time systems. CryoCheck INR Validation Set is not intended for use as calibration or reference plasma and should not be used for calibrating the local International Sensitivity Index (ISI) of commercial. thromboplastins.
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The provided text is a 510(k) premarket notification approval letter for the "CryoCheck™ INR Validation Set" and does not contain information regarding acceptance criteria, device performance, or a study report. The document primarily focuses on the FDA's determination of substantial equivalence to a legally marketed predicate device.
Therefore, I cannot extract the requested information such as acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth types, or training set details from the provided text.
§ 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.