(43 days)
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA 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-ß-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
This document is a 510(k) clearance letter from the FDA for a medical device called "Autostat II Anti-B-2 Glycoprotein I IGA Elisa." It confirms that the device is substantially equivalent to a legally marketed predicate device.
Unfortunately, the provided text does not contain the detailed study information needed to answer your questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study specifics. This document is a regulatory approval letter, not a scientific study report.
Therefore, I cannot provide the requested table and detailed answers based on the given input. The letter only states the device's name, regulation number, regulation name, regulatory class, and product code. It also includes the "Indications for Use" which describes what the device is intended for.
To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or the 510(k) submission itself, which would detail the performance studies conducted.
§ 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).