(32 days)
The CoaguChek System for professional use is intended for quantitative prothrombin time (PT) testing in fresh capillary or venous whole blood by professional health care providers. The CoaguChek System for Patient Self Testing is intended for the quantitative prothrombin time (PT) testing in fresh capillary blood by selected and suitably trained patients or their caregivers on the prescription of the treating physician.
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The provided text is a 510(k) premarket notification letter from the FDA, confirming that the CoaguChek System and CoaguChek PST devices are substantially equivalent to previously marketed devices. However, this document does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter focuses on regulatory approval, stating that the devices can be marketed subject to general controls and FDA regulations. It does not include the detailed technical study results that would describe how the device meets specific performance criteria.
Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need access to the actual 510(k) submission or supporting clinical study reports for the CoaguChek System.
§ 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.