(93 days)
Intended for the in vitro determination of mitochondrial (M2) antibody in human serum. Anti-M2 assays are used as an aid in the diagnosis of Primary Biliary Cirrhosis - CFR 866.5090
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The provided text is a 510(k) approval letter from the FDA for a device called "TRACE Enzymatic Mitochondria (M2) Antibody Reagent." This document does not contain the detailed information required to answer your questions about acceptance criteria and the study proving device performance.
Specifically, the letter is a regulatory filing indicating substantial equivalence to a previously marketed device, allowing it to be sold. It does not include:
- Details of a performance study.
- Acceptance criteria for such a study.
- Sample sizes for test or training sets.
- Information on expert ground truth, adjudication methods, or MRMC studies.
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§ 866.5090 Antimitochondrial antibody immunological test system.
(a)
Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).(b)
Classification. Class II (performance standards).