Celsius and Fahrenheit in 510k

invitro_spain

Involved In Discussions
#1
Hello folks,

I have a simple doubt about Temperature units. What is the best way to describe the temperature in a 510k? Options:

1.- Celsius (use in all the countries except the US according to Wikipedia information)
2.- Fahrenheit (use in the US)
3.- Both

Could you help me with your opinions, please?

Thanks
 
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JeantheBigone

Quite Involved in Discussions
#2
I would probably use both, the Celsius first and then the Fahrenheit in parentheses.

"25°C (77°F)"

The reason is that if you look at recognized consensus standards that are often used to support 510(k)s, like AAMI ST79, that is how they do it. ISO standards usually use Celsius only.

It probably depends on the type of product, for example if some processing step in the US is at all involved in the submission, I would include the Fahrenheit units.
 

Ajit Basrur

Staff member
Admin
#3
Hello folks,

I have a simple doubt about Temperature units. What is the best way to describe the temperature in a 510k? Options:

1.- Celsius (use in all the countries except the US according to Wikipedia information)
2.- Fahrenheit (use in the US)
3.- Both

Could you help me with your opinions, please?

Thanks
Since its a 510(K) for the US market, you should have the Fahrenheit. But if the product is exported to other countries, you need to have Celsius capabilities. Is your product design able to report both in C and F?

Just as an additional point for discussion, on the Food side of regulations, FDA is proposing metric equivalents of avoirdupois (U.S.)
measurements, to not only provide the temperature measurements in Fahrenheit, but to follow the Fahrenheit ([deg]F) measure with the units in Celsius ([deg]C).
 

invitro_spain

Involved In Discussions
#4
Since its a 510(K) for the US market, you should have the Fahrenheit. But if the product is exported to other countries, you need to have Celsius capabilities. Is your product design able to report both in C and F?

Just as an additional point for discussion, on the Food side of regulations, FDA is proposing metric equivalents of avoirdupois (U.S.)
measurements, to not only provide the temperature measurements in Fahrenheit, but to follow the Fahrenheit ([deg]F) measure with the units in Celsius ([deg]C).
Hi Ajit,

My question was about the documents, normally, included in the 510(k). I mean (Summaries, protocols and reports). Our device is a class II.

In any case, I agree with you regarding, for example, labeling, etc. You can design the labeling with the storage information in Celsius and Fahrenheit or design different labelings according to the country regulation. Actually, we designed labeling when the storage information was in Fahr. for the US. Nevertheless, my doubt raised regarding the protocols, etc.

Thank you for the support
 

Statistical Steven

Statistician
Staff member
Super Moderator
#5
It all depends on what you are reporting. If you are discussing a stability protocol, then Celsius is acceptable. If you are discussing range of temperature for use, then you need to report both. For example, in an invitro diagnostic test, reporting samples should be frozen for storage prior to testing, you can say stored at -20C for example.

Hi Ajit,

My question was about the documents, normally, included in the 510(k). I mean (Summaries, protocols and reports). Our device is a class II.

In any case, I agree with you regarding, for example, labeling, etc. You can design the labeling with the storage information in Celsius and Fahrenheit or design different labelings according to the country regulation. Actually, we designed labeling when the storage information was in Fahr. for the US. Nevertheless, my doubt raised regarding the protocols, etc.

Thank you for the support
 
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