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The TheraTest EL-ANA Profiles: EL-ENA/5 is an in vitro diagnostic test for the screening of autoantibodies in human serum directed against the following extractable nuclear antigens: Sm, nRNP, SSA, SSB and Scl70. This screening aids in the diagnosis of systemic lupus erythematosus and related autoimmune disorders.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving device performance. The document is a 510(k) clearance letter from the FDA for a device called "EL-ANA Profiles: EL-ENA/5." It primarily focuses on the regulatory clearance for marketing the device based on substantial equivalence to a predicate device.

The letter does not include:

• A table of acceptance criteria or reported device performance metrics.
• Details about sample sizes for test or training sets.
• Information on data provenance.
• The number or qualifications of experts used for ground truth.
• Adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Whether a standalone algorithm performance study was conducted.
• The type of ground truth used or how it was established for training data.

The relevant section for performance would typically be in the 510(k) submission itself, which is not provided here. The clearance letter only provides the "Indications for Use" and the determination of substantial equivalence.

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