Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | DIASORIN ETI-CORE-IGMK PLUS ASSAY |
Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. STILLWATER, MN 55082-0285 |
PMA Number | P990044 |
Date Received | 07/02/1999 |
Decision Date | 03/30/2001 |
Withdrawal Date
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10/10/2023 |
Docket Number | 01M-0455 |
Notice Date | 10/09/2001 |
Advisory Committee |
Microbiology |
Expedited Review Granted? | No |
Combination Product | No |
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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S007 S008 S009 S010 S011 S012 S014 S015 S016 S017 S018 S019 S020 S021 S022 S024 S025 S026 S027 S028 S029 |
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