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The EL-ANA Profiles™ is intended to measure autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), doublestranded DNA (dsDNA), Sm, RNP/Sm, SSA (Ro), SSB (La), Scl-70, Histones, Jo-1, Ribosomal Protein P , and Centromere. This system is intended as an aid in diagnosis of systemic lupus erythematosus and related rheumatic diseases.

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This is an FDA premarket notification (510(k)) letter for the EL-ANA Profiles™ device. The letter states that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.

Unfortunately, this document does not contain the detailed acceptance criteria or the study that proves the device meets those criteria. The letter is an official approval document, but it does not include the technical data and results of the clinical studies or performance validation studies. Such information is typically found in the 510(k) summary or the full 510(k) submission, which are separate documents.

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

To address your request fully, I would need to review the actual 510(k) summary or the entire 510(k) submission for K024151.

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