Serum albumin is measured with assays that use dye color methods with Bromocresol green (BCG). In the past decade or so, labs both within the USA and internationally have started moving away from BCG to Bromocresol purple (BCP)
Scenario: Currently our BCG albumin assay (class I in Japan) has been on the market for quite some time (6+years) and is also sold in the USA , Canada, Australia and EU. Japan market would like to switch over to the BCP assay as soon as available and so does Canada and AUS, the USA and some countries in EU are not interested in making the switch from BCG--> BCP.
We have a BCP assay currently being developed. Will this require a clinical study? and for whom (Japan? or for IVDR for CE mark?) Or does this only require a Reference interval study (healthy population)? Or maybe neither? The intended use language remains the same (as it was for BCG) which is “used for quantitative measurement of serum albumin in various diseases of liver kidney etc<-- other competitors albumin assays use the same language)
.Any insight appreciated. thank you
Scenario: Currently our BCG albumin assay (class I in Japan) has been on the market for quite some time (6+years) and is also sold in the USA , Canada, Australia and EU. Japan market would like to switch over to the BCP assay as soon as available and so does Canada and AUS, the USA and some countries in EU are not interested in making the switch from BCG--> BCP.
We have a BCP assay currently being developed. Will this require a clinical study? and for whom (Japan? or for IVDR for CE mark?) Or does this only require a Reference interval study (healthy population)? Or maybe neither? The intended use language remains the same (as it was for BCG) which is “used for quantitative measurement of serum albumin in various diseases of liver kidney etc<-- other competitors albumin assays use the same language)
.Any insight appreciated. thank you
