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Complement Activation

Complement Activation

The Complement Activation test is used to determine the potential for activation of the complement system by a medical device. This humoral immune response, caused by the introduction of a foreign material into the body, can lead to adverse effects such as tissue damage.

This test was designed to fulfill the immunology testing requirement found in the AAMI/ANSI/ISO 10993-4 guidelines for selection of tests for interactions with blood. Nelson Laboratories includes three time points in the assay to look at possible levels of activation over time.

Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA G95-1 Guidelines]

Applicable Standards

  • ANSI/AAMI/ISO 10993-4
  • ANSI/AAMI/ISO 10993-12

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
HCX230 Hemocompatibility: Complement Activation, C3a only, 1st test article 28 Add
HCX240 Hemocompatibility: Complement Activation, SC5b-9 only, 1st test article 28 Add
HCX245 Hemocompatibility: Complement Activation, SC5b-9, test & predicate 24 Add
HCX250 Hemocompatibility: Complement Activation, C3a and SC5b-9, 1st test article 28 Add
HCX255 Hemocompatibility: Complement Activation, C3a and SC5b-9, test & predicate 28 Add
HCX230 - Hemocompatibility: Complement Activation, C3a only, 1st test article
TAT: 28 days
HCX240 - Hemocompatibility: Complement Activation, SC5b-9 only, 1st test article
TAT: 28 days
HCX245 - Hemocompatibility: Complement Activation, SC5b-9, test & predicate
TAT: 24 days
HCX250 - Hemocompatibility: Complement Activation, C3a and SC5b-9, 1st test article
TAT: 28 days
HCX255 - Hemocompatibility: Complement Activation, C3a and SC5b-9, test & predicate
TAT: 28 days

Sample Specifications

HCX230: 18-30 cm2 per device
HCX240: 18-30 cm2 per device
HCX245: Sample Amount: 18 - 30cm² or 0.6 - 1 gram. Turn Around Time is 24 days from PDS approval.
HCX250: 18-30 cm2 per device
HCX255: 18-30 cm2 per device

Study Outline

The Complement Activation test is performed in vitro using commercially prepared Enzyme Immunoassay (EIA) kits that detect the presence of specific complement proteins:
  • C3a: An enzyme generated during the activation of the complements system via the classical or the alternate pathway
  • SC5b-9-complex: The soluble, non-lytic form of Terminal Complement Complex (TCC) generated as a consequence of activation of the complement system
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