(64 days)
The SPIFE 3000 TITAN GEL IgG IEF Kit is intended for the qualitative identification of IgG-specific oligoclonal banding in paired serum and CSF samples by agarose gel isoelectric focusing and immunoblotting, as an aid in the diagnosis of inflammatory disease of the central nervous system, such as caused by multiple sclerosis
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The provided text is a 510(k) clearance letter from the FDA for a device called "SPIFE 3000 Titan Gel IgG IEF Kit". This document primarily focuses on regulatory approval based on substantial equivalence, and not on the detailed reporting of a study that establishes acceptance criteria and proves the device meets them in the way modern AI/ML device submissions would.
Therefore, the information you're requesting regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in the provided text.
The document states the indications for use: "The SPIFE 3000 TITAN GEL IgG IEF Kit is intended for the qualitative identification of IgG-specific oligoclonal banding in paired serum and CSF samples by agarose gel isoelectric focusing and immunoblotting, as an aid in the diagnosis of inflammatory disease of the central nervous system, such as caused by multiple sclerosis."
However, it does not include the detailed performance study results that would typically define "acceptance criteria" and "reported device performance" in the format you've requested. The FDA's 510(k) clearance process for this type of device (from 2003) often relies on demonstrating substantial equivalence to a predicate device rather than presenting extensive, de novo clinical trial data with predefined acceptance metrics and detailed statistical analysis on a test set.
In summary, the input text does not contain the information necessary to fulfill your request for: a table of acceptance criteria and reported device performance, sample sizes and data provenance for test sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
§ 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).