(175 days)
The KRONUS Insulin Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to insulin in human serum. The KRONUS Insulin Autoantibody RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.
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This document is a 510(k) premarket notification letter from the FDA to KRONUS Market Development Associates, Inc. for their Insulin Autoantibody RIA Kit. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.
The letter only states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance for market. It refers to "indications for use" but does not provide performance metrics or study details.
Therefore, I cannot extract the requested information from the provided text.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).