Diasorin Eti-Core-Igmk Plus Assay

Approval order statement

APPROVAL FOR THE DIASORIN ETI-CORE-IGMK PLUS ASSAY. THE DEVICE IS INDICATED FOR: ETI-CORE-IGMK PLUS IS AN IN VITRO ENZYME IMMUNOASSAY(EIA) INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-CORE-IGMK PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT. THE PRESENCE OF IGM ANTI-HBC, IN THE PRESENCE OF TOTAL ANTIBODY TO HBC (ANTI-HBC) IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR ACUTE INFECTION. THE ABSENCE OF IGM ANTI-HBC, IN THE PRESENCE OF TOTAL ANTI-HBC, IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR RECOVERY FROM HBV INFECTION. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ETI-CORE-IGMK PLUS ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. THIS ASSAY HAS NOT BEEN FDA-APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS.