Use of Automated Liquid Handling Robot for a PCR based Assay

[raqamanager]

Hello users,

I work for a company which is developing an IVD medical device comprising a PCR based assay. We are ISO9001:2008 and ISO13485:2003 certified. We are using an automated liquid handling robot in the research and development phase to try and replicate the assay conducted by technicians. It is our intention that the assay to be sold commercially is conducted using an automated liquid handling robot.

I am confused about the regulatory implications of determining performance characteristics using the robot and specifying these performance characteristics in a CE submission. If we use the robot for determining performance characteristics are we limiting ourselves to selling an assay which can only be used using a liquid handling robot or can it be used using normal 'Gilson' type pipettes?

Many thanks

 

[kanwal]

Having arrived at the formulation for the PCR assay, you will be using measurements alone in your documentation - as you are discussing the replacement of the Automated Liquid Handling Robot by the pipette - an equivalence of the measurements accuracy is really needs to be established. That is the least count of the automated liquid handling robot should match that of the recommended pipettes.

If you cannot do that then you need to establish the same in house for the pipettes or establish that there is no significance in the assay performance for errors between the two least counts.

 

[pzucchel]

Hi,

for clarity and honesty, i need to disclose i am actually working for the company Andrew Alliance so i will limit myself to a technical statement without entering into commercial considerations.

In our robot, we use EXACTLY the same mechanical pipettes used by manual users, without modifications. In this context, i would argue that the same certification process would apply. Additionally, our CaliBro accessory allows to user to validate both the ISO8655 pipette compliance and the GxP compliance of the unit, so i would argue that the same device could be used to validate the PQ for both manual and automated user. it seems to me an important technical feature in the precise IVD context you're mentioning.

you can find the relevant information on our website.