Can anyone please shed some light on external control kit for IVD test kit?
Currently we have an IVD test kit in the process to submit for 510(k). The external control kit is planned and we are deciding whether to include the control in this round of 510(k) or add it later.
1. What studies are needed to support an external control kit?
2. If submitted later, is this a modification 510(k) or a totally separate new 510(k)? What studies are required?
Thank you.
Currently we have an IVD test kit in the process to submit for 510(k). The external control kit is planned and we are deciding whether to include the control in this round of 510(k) or add it later.
1. What studies are needed to support an external control kit?
2. If submitted later, is this a modification 510(k) or a totally separate new 510(k)? What studies are required?
Thank you.