(150 days)
The DiaPharma Factor X Kit is an in vitro diagnostic test kit for the quantitative determination of Factor X activity in human citrated plasma.
Factor X activity is useful for monitoring patients on oral anticoagulant therapy (warfarin) where baseline PT values may be prolonged and INR results are not reliable, such as in OAC patients with lupus inhibitors. The DiaPharma FX kit provides health care providers with a tool for with Tapac Innovelor The DiaPharma Factor X Kit is also useful for screening for factor X deficiencies.
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The provided document does not contain information about acceptance criteria or a study that proves a device meets such criteria. This document is a 510(k) premarket notification letter from the FDA to DiaPharma Group, Inc. for their DiaPharma Factor X Kit. It primarily confirms the substantial equivalence of the device to a legally marketed predicate device and outlines regulatory compliance requirements.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study demonstrating compliance. This type of detailed performance data is typically found in a clinical study report or a more extensive technical file, not in the FDA's initial 510(k) clearance letter.
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).