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Reagent equivalency requirement

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Guest user Created:   Apr 27, 2021 Last commented:   Apr 28, 2021

Reagent equivalency requirement

Can you please direct me to a part in regulation on lab reagent equivalency requirement?
I am involved in project to asses equivalencies of reagents used in lab but not entirely sure where to go for information on requirements for performing equivalency study of reagents for analytical test method

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ISO 13485 DOCUMENTATION TOOLKIT

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Apr 28, 2021

Equivalent device in the meaning of the In vitro diagnostic device regulation (IVDR 2017/746) is considered as equivalent when the device in question is either almost identical or completly identical to the comparator device. In order to demonstrate equivalent performance, a systematic methodological comparison is required, where performance should correspond to the performance of a comparator device within the pre-defined limits. 

Some of the elements according to which equivalence can be made a presented bellow (regarding the product composition, design, features, or intended purpose). Please keep in mind that this is not the whole list, it is manufacturer's responsibility to define appripriate concept, considering the type of the IVD device:

-        Technology (for example is it ELISA, PCR, spectroscopy...)

-        Device design (for example what is a sample volume, what are the processing and incubation time, critical reaction component(s))

-        Is it automated or manual system

-        What are analytical performance characteristics

-        Which Specimen type(s) are used (blood, urine, saliva, plasma)

-        Biological controls

-        Are antibodies used polyclonal or monoclonal

-        What is intended purpose 

-        Who are target population 

-        Who are Intended user (professional use, near patient test, self-testing) 

-        Are there any test limitations 

-        Scientific validity 

-        Clinical performance 

-        Clinical benefit

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Apr 27, 2021

Apr 28, 2021