(580 days)
This assay is designed for the in vitro measurement of human IgM in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal IgM metabolism.
Not Found
This document is a 510(k) clearance letter from the FDA for an "IgM Minineph Antiserum" device. It is not a study report or clinical trial summary. Therefore, none of the requested information about acceptance criteria, device performance, test sets, ground truth, or study methodologies can be extracted from this document.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements...". This indicates that the device was cleared based on substantial equivalence to existing devices, not necessarily on a novel clinical study with explicit acceptance criteria and performance metrics detailed in this letter.
The "Indications for Use Statement" on the third page describes what the device is for, but not how its performance was evaluated against specific criteria.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).