(54 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 ENA Screen ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies to all six common extractable nuclear antigens (SSA, SSB, Sm, Sm/RNP, Jo-1 and Scl-80).
Not Found
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria, study details, or device performance.
The document is an FDA 510(k) clearance letter for a device called "Aptus (Automated) Application for the ENA Screen Test System." It confirms that the device is substantially equivalent to a predicate device and can be marketed.
While it mentions the indications for use of the ENA Screen ELISA test system (intended for manual or automated analysis of human serum for IgG antibodies to specific nuclear antigens to assist in the diagnosis of connective tissue diseases), it does not contain any data, study results, or specific performance metrics which would allow me to answer your detailed questions about acceptance criteria and study design.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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).