(104 days)
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgM autoantibodies to ß-2 Glycoprotein-I (ß-2 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
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Autostat™II Anti-ß2 Glycoprotein -I IgM ELISA." This document grants market clearance based on substantial equivalence to a predicate device, rather than providing a detailed study report demonstrating device performance against specific acceptance criteria.
Therefore, the information required to answer the prompt (acceptance criteria, study details, expert qualifications, etc.) is not present in the provided text. The letter primarily focuses on the regulatory aspects of device clearance.
To answer the prompt, I would need access to the actual 510(k) submission or a detailed study report for the "Autostat™II Anti-ß2 Glycoprotein -I IgM ELISA" device.
§ 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).