(590 days)
The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is for the qualitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum. The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.
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This document is an FDA clearance letter for an in vitro diagnostic (IVD) device, specifically an ELISA kit. It does not contain information about an AI/ML-driven medical device study or its performance characteristics. Thus, most of the requested information regarding acceptance criteria, study design, ground truth establishment, and expert involvement for an AI medical device cannot be extracted from this document.
The document discusses the clearance of the KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (K220085) for the qualitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum, to be used as an aid in the diagnosis of Type 1 diabetes mellitus.
Therefore, I cannot provide the requested information based on the provided text. The questions are specifically tailored for an AI/ML device study, not for an ELISA kit's regulatory clearance.
§ 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).