(62 days)
The QUANTA Lite™ RF IgA ELISA is a semiquantitative enzymelinked immunosorbent assay (ELISA) for the detection of IgA rheumatoid factor (RF) antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis (RA).
Not Found
This appears to be a 510(k) clearance letter from the FDA for a diagnostic device, the QUANTA Lite™ RF IgA ELISA. This type of document typically does not contain the detailed study information required to answer your specific questions about acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials with detailed performance metrics and reader studies as might be found for a new, high-risk device.
Therefore, I cannot provide the requested information from the provided text.
Here's why and what kind of document would contain this information:
- Acceptance Criteria and Device Performance Table: This would be found in a comprehensive clinical study report, a validation study report, or potentially within the detailed 'Device Description' or 'Performance Data' sections of a full 510(k) submission, but not usually in the summary clearance letter itself.
- Sample Size, Data Provenance, Expert Qualifications, Adjudication Method, MRMC Studies, Standalone Performance, Ground Truth Type, Training Set Size, Training Ground Truth: All these details are specific to the design and execution of performance studies (clinical and analytical) and would be thoroughly documented in the full 510(k) submission's "Performance Data" or "Clinical Studies" sections. The clearance letter only summarizes the outcome of the FDA's review.
To get the information you are asking for, you would typically need to review the full 510(k) submission document itself, which is often much more extensive than the public clearance letter. Some submissions are available through the FDA's databases, but their level of detail can vary.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).