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  • 1.  Complement Activation Test

    Posted 18-Sep-2018 17:09
    Hi All:
    Recently we have seen a large increase the requirement for this test. I was wondering if any of the community has experienced an increase in this or other ISO 10993 test requirements. One request I can chalk up to a reviewers interest area, however, with multiple requests, is there a change in view from the agency?  The Complement Activation test is part of the hemocompatibility suite of testing within Biocompatibility mostly towards implanted devices. Performing the entire 10993 suite of tests is way too costly. Any input is appreciated.

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    Gregory Kleinert
    Sr Director
    Biocoat, Inc.
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  • 2.  RE: Complement Activation Test

    Posted 19-Sep-2018 08:41
    The latest version of 10993-1 was just issued, and if not read carefully, can lead one to believe a lot of testing is necessary. While I have seen some trends for more testing, with better materials characterization and well written biological evaluations, the amount of testing can be mitigated.

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    Lisa Olson
    Minneapolis MN
    United States
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    Original Message


  • 3.  RE: Complement Activation Test

    Posted 19-Sep-2018 09:53
    ​For legacy devices (those already on the market for years), is this new biocompatibility testing suite necessary? Would it be necessary to have chemical characterization testing to determine this?

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    Stacy
    Boulder CO
    United States
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    Original Message


  • 4.  RE: Complement Activation Test

    Posted 19-Sep-2018 13:30
    What we have seen appears to be for new device applications. The test itself is usually done comparatively to a predicate device, which device. 
    The test is big $, gauging any tendencies towards requiring this test. This is specifically listed in the 10993-4 (017).

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    Gregory Kleinert
    Warrington PA
    United States
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    Original Message


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