(40 days)
The PolyTiter Immunofluorescent Titration System including the calibrator solutions is designed to assist in the semiquantitative determination (titer/pattern) of the and no Te-aDiscRips System may be in the in vitro microscopic immuno-fluorescent assay. The PolyTiter System may be used as an aid in the diagnosis and management of autoimmune diseases.
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The provided text is a 510(k) summary for the PolyTiter Immunofluorescent Titration System. It primarily outlines the regulatory approval for marketing the device and its intended use. Crucially, this document does not contain the detailed acceptance criteria or the study results that demonstrate the device meets those criteria.
Therefore, I cannot provide most of the requested information, including:
- Table of acceptance criteria and reported device performance: This is not in the document.
- Sample size for the test set and data provenance: No information on these aspects of a study is provided.
- Number of experts and qualifications for ground truth: Not mentioned.
- Adjudication method: Not described.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone performance study: Not mentioned.
- Type of ground truth used: Not specified in relation to a performance study.
- Sample size for the training set: Not provided.
- How ground truth for the training set was established: Not provided.
The document indicates that the system is "designed to assist in the semiquantitative determination (titer/pattern) of autoantibodies and other analytes by in vitro microscopic immuno-fluorescent assay" and "may be used as an aid in the diagnosis and management of autoimmune diseases." However, it does not offer the specific performance data to back these claims in the context of a study.
This document is a marketing authorization letter, not a detailed technical report of device validation.
§ 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).