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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

Pricing/Quote

Test Price Request Quote
HCX230 - Hemocompatibility: Complement Activation, C3a only, 1st test article
Per test1+$3,025.00
Add
HCX231 - Hemocompatibility (GLP): Complement Activation, C3a only, 1st test article
Per test1+$3,480.00
Add
HCX240 - Hemocompatibility: Complement Activation, SC5b-9 only, 1st test article
Per test1+$3,025.00
Add
HCX241 - Hemocompatibility (GLP): Complement Activation, SC5b-9 only, 1st test article
Per test1+$3,480.00
Add
HCX250 - Hemocompatibility: Complement Activation, C3a and SC5b-9, 1st test article
Per test1+$6,055.00
Add
HCX251 - Hemocompatibility (GLP): Complement Activation, C3a and SC5b-9, 1st test article
Per test1+$6,960.00
Add
HCX255 - Hemocompatibility: Complement Activation, C3a and SC5b-9, test & predicate
Per test1+$7,200.00
Add
HCX256 - Hemocompatibility (GLP): Complement Activation, C3a and SC5b-9, test & predicate
Per test1+$8,280.00
Add
HCX230 - Hemocompatibility: Complement Activation, C3a only, 1st test article
Per test1+$3,025.00
HCX231 - Hemocompatibility (GLP): Complement Activation, C3a only, 1st test article
Per test1+$3,480.00
HCX240 - Hemocompatibility: Complement Activation, SC5b-9 only, 1st test article
Per test1+$3,025.00
HCX241 - Hemocompatibility (GLP): Complement Activation, SC5b-9 only, 1st test article
Per test1+$3,480.00
HCX250 - Hemocompatibility: Complement Activation, C3a and SC5b-9, 1st test article
Per test1+$6,055.00
HCX251 - Hemocompatibility (GLP): Complement Activation, C3a and SC5b-9, 1st test article
Per test1+$6,960.00
HCX255 - Hemocompatibility: Complement Activation, C3a and SC5b-9, test & predicate
Per test1+$7,200.00
HCX256 - Hemocompatibility (GLP): Complement Activation, C3a and SC5b-9, test & predicate
Per test1+$8,280.00

Turn Around Time

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT
HCX230 Hemocompatibility: Complement Activation, C3a only, 1st test article 28
HCX231 Hemocompatibility (GLP): Complement Activation, C3a only, 1st test article 28
HCX240 Hemocompatibility: Complement Activation, SC5b-9 only, 1st test article 28
HCX241 Hemocompatibility (GLP): Complement Activation, SC5b-9 only, 1st test article 28
HCX250 Hemocompatibility: Complement Activation, C3a and SC5b-9, 1st test article 28
HCX251 Hemocompatibility (GLP): Complement Activation, C3a and SC5b-9, 1st test article 28
HCX255 Hemocompatibility: Complement Activation, C3a and SC5b-9, test & predicate 28
HCX256 Hemocompatibility (GLP): Complement Activation, C3a and SC5b-9, test & predicate 28
Code TAT
HCX230 28
HCX231 28
HCX240 28
HCX241 28
HCX250 28
HCX251 28
HCX255 28
HCX256 28

Sample Specifications

HCX230: 60 cm2 or 2 grams
HCX231: 60 cm2 or 2 grams
HCX240: 60 cm2 or 2 grams
HCX241: 60 cm2 or 2 grams
HCX250: 60 cm2 or 2 grams
HCX251: 60 cm2 or 2 grams
HCX255: 60 cm2 or 2 grams each (test & predicate)
HCX256: 60 cm2 or 2 grams each (test & predicate)

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