IVD instrument as an accessory

#1
Hello everyone,

My company makes an analyser device which works on the principle of microscopy and spectrometry. This analyser has many uses, from environmental analysis to veterinary urin analysis. The only difference is the software. One has to install and use different software for different application. Now, we want to use this device (hardware) as an ivd device.

I wanted to find a way where I can market this device as a general platform on which different software can be used for different application. Is it possible to give a generalized intended purpose to the device so that I don't need to change its intended purpose, every time we make a new software for a new application of this device? Is it possible to make an intended purpose of the device without including the medical indication?

I know that for every software we will need the CE marking. Is it possible that we can make the software as a stand alone medical device and the device as its accessory? So that we don't need to add the medical indication for the device.

Thanks for your answers.

Regards,
Jaimin
 
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shimonv

Trusted Information Resource
#2
Hi Jaimin,
Th intended use / indication for use are the most important definitions in a medical device law. Based on these we determine if a device is a medical device or not; what is its classification; and what are the applicable regulatory requirements.

You cannot have a medical device or IVD without being somewhat specific about what it does. No such thing as generalised intended purpose.

-Shimon
 
#3
Hi Jaimin,
The intended use / indication for use are the most important definitions in a medical device law. Based on these we determine if a device is a medical device or not; what is its classification; and what are the applicable regulatory requirements.

You cannot have a medical device or IVD without being somewhat specific about what it does. No such thing as generalised intended purpose.

-Shimon
Hi Shimon,

Thank you for your reply. I had this question after I was looking through the brochure of one of the analyzer from Roche Diagnostics. Here is what they described their system.

Cobas c 311 analyzer: "Automated, discrete clinical chemistry analyzer intended for the in vitro quantitative/qualitative determination of analytes in body fluids"

Here, I see that there is no medical indication here. The device is used for the determination of analytes in body fluids. I think in this case, it is not even possible to classify the device.

Is it possible that the device is some kind of instrument for general laboratory purposes and marketed as an accessory along with the IVD kits which have specific medical indication for their intended purposes.

Regards,
Jaimin
 

shimonv

Trusted Information Resource
#4
Jaimin,
I could not find the Cobas c 311 analyzer in FDA database, but I did find cobas c 513 Analyser and assay. The indications for use statement says:

Device Name
1593339332016.png
cobas c 513 Analyzer
cobas c 513 Tina-quant HbA1cDx Gen.3 Assay
1593339332054.png
Indications for Use (Describe)
The cobas c 513 clinical chemistry analyzer is a fully automated, standalone clinical chemistry analyzer intended for the
in-vitro quantitative determination of analytes in body fluids.


The Tina-quant Hemoglobin A1cDx Gen.3 assay is intended for use as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. It is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood on the Roche/Hitachi cobas c 513 clinical chemistry analyzer. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Is it possible that the device is some kind of instrument for general laboratory purposes and marketed as an accessory along with the IVD kits which have specific medical indication for their intended purposes.
Yes, it's possible. A simple example would be a foot pedal connected to and IVD analyser.
A more complex situation required a thorough regulatory assessment.

Shimon
 
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