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The EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern test kit is intended for the qualitative and semiquantitative determination of human antibodies of immunoglobulin class IgG against anti-double stranded DNA (dsDNA) in human serum with the EUROPattern Microscope and Software automated instrument. It is a sensitive method, used as an aid in the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

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This is an FDA 510(k) clearance letter for a medical device. It does not contain the detailed study information needed to answer the questions about acceptance criteria, device performance, and study design. The letter confirms that the device, "EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern," has been found substantially equivalent to a predicate device for aiding in the diagnosis of systemic lupus erythematosus (SLE).

To answer your questions, I would need access to the full 510(k) submission, which would include the performance studies and acceptance criteria agreed upon with the FDA. This information is typically not publicly available in the clearance letter itself.

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