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510(k) Submission for Outsourced Automated Instrumentation System Components

T

tennis_girl

#1
We are purchasing an automated instrumentation system from a manufacturer who will develop the system to our specification based on existing platforms that they already manufacture. We will conduct all the testing in-house and file the Classs II 510(k) for the finished system.

I've reviewed the applicable guidance doc for this type of instrument however I want to know if we need to test each of subassembly/components seperately before they are integrated into the finished system or only as a finished system which they are providing?

Thanks in advance
 
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BradM

Staff member
Admin
#2
Re: 510(k) submission for outsourced instrument

Hello! Welcome to the Cove!:bigwave:

Exactly what kind of testing are you looking to perform on this equipment?

What will the automated equipment be doing for you?
 
T

tennis_girl

#3
510(k) submission for outsourced instrument

The system will be automating assays that are normally done by hand. This would involve pipetting, aspirating, reagent handling, centrifugation, to name a few. We will be running performance assays and compare them with the current methodology (manual), also stress, reproducibility etc..
I want to know if I have to test each subassembly i.e. pipettor for actual output volumes or can I use the manufacturer performance data for that part of the system.
Thanks
 
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