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The RhiGene MESACUP ANA TEST is a semi-quantitative enzyme-linked immunosorbent assay for the detection of disease specific antinuclear antibodies in human serum. The RhiGene MESACUP ANA TEST is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.

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The provided text describes a 510(k) premarket notification for the "RhiGene MESACUP ANA TEST" and confirms its substantial equivalence to a legally marketed predicate device. However, the document does not contain the specific information required to complete the table and answer the questions about acceptance criteria, study details, ground truth establishment, or sample sizes.

The document is primarily an FDA clearance letter for a medical device (an in-vitro diagnostic test), and as such, it focuses on the regulatory determination of substantial equivalence rather than providing detailed study protocols or results.

To fulfill the request, one would typically need access to the full 510(k) submission, which would include the performance data and the study's design.

Therefore, I cannot provide the requested information based solely on the text provided.

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The RhiGene ANA ELISA TEST SYSTEM is a semi-quantitative enzyme-linked immunosorbent assay for the detection of disease specific antinuclear antibodies in human serum. The RhiGene ANA ELISA TEST SYSTEM is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.

The RhiGene ANA ELISA TEST SYSTEM uses a mixture of recombinant purified proteins of Jo-1, RNP, SS-A, SS-B, Scl-70, CENP-B and native purified proteins of SS-A, Sm, dsDNA and ssDNA for the solid phase antigen. Therefore, the test shows increased specificity for detection of disease-specific connective tissue diseases such as SLE, Progressive Systemic Sclerosis, Mixed Connective Tissue Diseases, Sjögren's Syndrome, and Polymyositis.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "RhiGene ANA ELISA TEST SYSTEM." It primarily confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain the requested information about acceptance criteria or a study proving the device meets them.

The document states the device's indications for use and mentions it's a semi-quantitative ELISA for detecting disease-specific antinuclear antibodies in human serum, intended as an aid in determining certain autoimmune diseases. It also lists the specific antigens used.

However, it does not include any performance data, study designs, sample sizes, ground truth establishment, or expert information. Therefore, I cannot provide a table of acceptance criteria or details of a study from this document.

Ask a specific question about this device