510(k) Submission for Outsourced Automated Instrumentation System Components

[tennis_girl]

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

 

[BradM]

Re: 510(k) submission for outsourced instrument

Hello! Welcome to the Cove!

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

What will the automated equipment be doing for you?

 

[tennis_girl]

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