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The Zeus Scientific, Inc. AtheNA Multi-Lyte® ANA Test System is intended for the semiquantitative detection of IgG class antibody to 8 separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, and Chromatin) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum and the qualitative detection of IgG class antibody to ANA in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune disorders. This test is for in vitro diagnostic use.

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I apologize, but the provided text is a cover letter from the FDA regarding a 510(k) premarket notification and identifies the device as the "AtheNA Multi-Lyte™ ANA-II Test System." It states the indications for use but does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, nor can I provide information on:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set or data provenance
• Number of experts and their qualifications for ground truth
• Adjudication method
• MRMC comparative effectiveness study or effect size
• Standalone performance (algorithm only)
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

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