(48 days)
The presence of autoantibodies to a number of nuclear constituents has proven to be useful in the diagnosis of various connective tissue diseases. Although the exact etiology of autoimmune diseases is unknown, and the specific role played by autoantibodies in the onset of various autoimmune connective tissue diseases is obscure, the association and frequency of detection of these antibodies may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases.
The Sm/RNP ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies Sm/RNP.
Not Found
The provided text is a 510(k) clearance letter for the "Aptus (Automated) Application for the Sm/RNP Test System". It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain the information requested regarding acceptance criteria studies, such as:
- A table of acceptance criteria and reported device performance: This information is typically found in the predicate device comparison section of a 510(k) submission, not the clearance letter itself.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results (effect size).
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on:
- The FDA's decision of substantial equivalence.
- Regulatory classification (Class II, Product Code LKO).
- General controls provisions of the Act.
- Contact information for various FDA offices.
- The intended use of the device, which is for the manual or automated analysis of human serum for the presence or absence of IgG antibodies to Sm/RNP, aiding in the diagnosis of connective tissue diseases.
Therefore, I cannot provide the answer to your request based on the provided text. The information needed to describe the acceptance criteria and the study proving the device meets them is not present in this 510(k) clearance letter. This type of information would be detailed within the actual 510(k) submission documents, particularly the performance data section, which is not attached here.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).