Biocompatibility - Complement System Testing

S

smithkaren109

#1
Hi,
I would greatly appreciate some advise on ISO 10993 complement System Testing (C3a and SC59-b). I understand that C3a is more difficult to detect (shortlived) and thus if I have a positive SC59-b with a negative C3a, I may still be considered potentially activating.

Does anyhow know how I can determine what an acceptable complement activation limit is? If a test device is only ~10% of the positive control (latex) in terms of SC59-b activation; yet significantly greater than the negative controls, how do I or the regulatory authorities (e.g., FDA) define the limit to when the test article is a complement system activator?

I have tried to look in the literature for some ideas but to no avail. Would be very grateful for some insights.

Thank you in advance
Karen
 
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Stijloor

Leader
Super Moderator
#2
Hi,
I would greatly appreciate some advise on ISO 10993 complement System Testing (C3a and SC59-b). I understand that C3a is more difficult to detect (shortlived) and thus if I have a positive SC59-b with a negative C3a, I may still be considered potentially activating.

Does anyhow know how I can determine what an acceptable complement activation limit is? If a test device is only ~10% of the positive control (latex) in terms of SC59-b activation; yet significantly greater than the negative controls, how do I or the regulatory authorities (e.g., FDA) define the limit to when the test article is a complement system activator?

I have tried to look in the literature for some ideas but to no avail. Would be very grateful for some insights.

Thank you in advance

Karen
Can someone help Karen with her question?

Thank you!!

Stijloor.
 
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