Dear all,
I am currently struggling with a situation. Company X produces an IVD medical device clinical analyzer (is class 1 - code JJE) - not quite an open system. Company Y developed the assays on the device and because the assay is class 2 they need to either submit the registration in USA as a system - 510k needed or they will submit de 510k for the assay and reference the company X device master file which the device company will give directly to FDA.
1. Does this mean the company X has now a device that is class 2? does it need a separate 510k?
2. Can other assay manufacturers reference the MAF for their assay class 2 submission?
3. If the device is already registered the market as a system (together with an assay) does this mean it can be now go through the MAF process for this other assay manufacturer to be referenced? what is the process?
I can't seem to find enough information on how to handle situations in which company X produces the device (technically as class 1) and other Y, Z, W companies develop their assay on it
Thank you
I am currently struggling with a situation. Company X produces an IVD medical device clinical analyzer (is class 1 - code JJE) - not quite an open system. Company Y developed the assays on the device and because the assay is class 2 they need to either submit the registration in USA as a system - 510k needed or they will submit de 510k for the assay and reference the company X device master file which the device company will give directly to FDA.
1. Does this mean the company X has now a device that is class 2? does it need a separate 510k?
2. Can other assay manufacturers reference the MAF for their assay class 2 submission?
3. If the device is already registered the market as a system (together with an assay) does this mean it can be now go through the MAF process for this other assay manufacturer to be referenced? what is the process?
I can't seem to find enough information on how to handle situations in which company X produces the device (technically as class 1) and other Y, Z, W companies develop their assay on it
Thank you
