(48 days)
The K-ASSAY C1-INA Assay is intended for the quantitative determination of human Complement-1 Inactivators in human plasma by immunoturbidimetric assay for hereditary angioedema. FOR IN VITRO DIAGNOSTIC USE.
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I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an "Indications for Use Statement" for the K-ASSAY Complement-1 Inactivator (C1-INA) device. This document does not include information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.
The information primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed subject to general controls. It does not contain the technical details of the validation studies conducted for the device.
§ 866.5250 Complement C
1 inhibitor (inactivator) immunological test system.(a)
Identification. A complement C1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).(b)
Classification. Class II (performance standards).