A New 510 k Paradigm

A new 510(k) paradigm provides guidance for sponsors of 510(k)s to consider and use national and international standards and a mechanism for declaration of conformity assessment criteria for these standards. It is expected that many domestic and international standards will address, in part or full, certain aspects of 

Intended use/ndica- The assay values in human The assay values in human 

Antigen measured Mucins encoded by the human MUCI gene Mucins encoded by the human MUCI gene 

Assay principle Radioimmunoassay (RIA) Microparticle enzyme immunoassay (MEIA) 

Detection of immuno- Antigen in sample competes with Antigen in sample is bound 

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