510(k) for a control kit for an external IVD test kit

#1
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.
 
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shimonv

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#2
Well, you should first assess what is the FDA classification for the QC kit.
If it's class I, then you can easily add later on.
If it's class II, then you should consider including it with the current submission.

Shimon
 
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