(81 days)
The QUANTA Lite™ CCP IgG ELISA is a semi-quantitative enzyme-linked immunosorbent assay for the detection of IgG anti-CCP (Cyclic Citrullinated Peptide) 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.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the QUANTA Lite™ CCP IgG ELISA device. It approves the device as substantially equivalent to a legally marketed predicate device.
However, the document does not contain specific information about:
- Acceptance criteria for device performance
- Detailed study design or results
- Sample sizes for test or training sets
- Data provenance or expert qualifications
- Adjudication methods
- MRMC comparative effectiveness studies
- Standalone algorithm performance
- Ground truth establishment methods
Therefore, I cannot provide the requested table or answer the specific questions related to the study design and acceptance criteria from the given extract. The document mainly serves as a regulatory approval notice.
§ 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).