(104 days)
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to ß2-Glycoprotein I (ß2-GPI) antibodies in human serum.
Uses:
The results of the anti- ß -2 GPI assay can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-B-2 GPI antibodies including antiphospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
This device can be used with the HYCOR HY•TEC automated EIA instrument.
For in vitro diagnostic use only.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a diagnostic device called Autostat™I Anti-ß2 Glycoprotein -IgG ELISA. This letter primarily focuses on the FDA's decision regarding the substantial equivalence of the device to a legally marketed predicate device, rather than providing a detailed study report with acceptance criteria and device performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided text.
This document confirms the device's clearance for marketing, states its intended use as an aid in diagnosing autoimmune diseases associated with elevated anti-ß2 GPI antibodies, and specifies that it is for in vitro diagnostic use only. It also mentions that the device can be used with the HYCOR HY•TEC automated EIA instrument. However, it does not include the technical study data that would typically contain the requested information.
§ 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).