(123 days)
The QUANTA Lite™ Actin ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum. Detection of these antibodies is an aid in diagnosis of certain autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).
The QUANTA Lite™ Actin ELISA kit is an enzyme-linked immunosorbent assay (ELISA).
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the "QUANTA Lite™ Actin ELISA" device, confirming its substantial equivalence to a legally marketed predicate device.
While it mentions the device and its indications for use, it does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance (test or training set).
- Information on experts, ground truth establishment, or adjudication methods.
- Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
The letter is a regulatory approval document, not a detailed study report.
§ 866.5120 Antismooth muscle antibody immunological test system.
(a)
Identification. An antismooth muscle antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antismooth muscle antibodies (antibodies to nonstriated, involuntary muscle) in serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's own tissues).(b)
Classification Class II (performance standards).