(81 days)
The QUANTA Lite™ gp210 kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-gp210 antibody of the IgG class in human serum. In an appropriate clinical context, results are intended to aid in the diagnosis of primary biliary cirrhosis (PBC).
The QUANTA Lite™ gp210 kit is an enzyme-linked immunosorbent assay (ELISA).
This is an FDA 510(k) clearance letter for the QUANTA Lite™ gp210 ELISA kit, which is an in vitro diagnostic device. The provided text is a regulatory document and does not contain the detailed study information typically found in a clinical trial report or scientific publication that would describe acceptance criteria and primary study results.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or specific study designs (MRMC, standalone). This document focuses on regulatory approval rather than the technical details of the validation study.
To answer your request, I would need access to the actual 510(k) submission document or a separate performance study report for the QUANTA Lite™ gp210 ELISA.
The letter only states:
- Trade/Device Name: QUANTA Lite™ gp210 ELISA
- Indication For Use: For the semi-quantitative detection of anti-gp210 antibody of the IgG class in human serum. Anti-gp210 antibodies are an aid in the diagnosis of primary biliary cirrhosis (PBC).
- Regulatory Class: Class II
- Product Code: NRI
- 510(k) Number: K040885 (though the initial blank is not filled, it is mentioned below as K040885)
Without the underlying study data, I cannot provide the specific details you've asked for.
§ 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).