(89 days)
The Optilite® IgG4 Kit is intended for the quantitative in vitro measurement of IgG4 in serum using the Binding Site Optilite analyser. Measurement of this immunoglobulin is an aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test result should be used in conjunction with other laboratory and clinical findings.
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I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Optilite® IgG4 Kit, which confirms that the device is substantially equivalent to a predicate device. It specifies the intended use of the device but does not detail the acceptance criteria, study design, sample sizes, ground truth establishment, or any information about AI assistance or human reader performance.
§ 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).