The Partial Thromboplastin Time (PTT) test is a general screening test for the detection of coagulation abnormalities in the intrinsic pathway. This test is performed on devices/materials that have direct contact with circulating blood.
Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA G95-1 Guidelines]
- ANSI/AAMI/ISO 10993-4
- ANSI/AAMI/ISO 10993-12
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|HCX220||Hemocompatibility: Partial Thromboplastin Time (PTT), Human plasma||Add|
|HCX225||Hemocompatibility: Partial Thromboplastin Time (PTT), Human plasma, test & predicate||Add|
HCX220 - Hemocompatibility: Partial Thromboplastin Time (PTT), Human plasma
TAT: 14 days
HCX225 - Hemocompatibility: Partial Thromboplastin Time (PTT), Human plasma, test & predicate
TAT: 14 days
HCX220: 1 device or 12-24 cm2
HCX225: 1 device or 12-24 cm2 each (test article & predicate)
The Partial Thromboplastin Time (PTT) assay was developed from the plasma recalcification and uses a PTT reagent as a platelet substitute. The sample is exposed to citrated plasma for 60 minutes at a validated temperature. The exposed plasma is divided into six replicates and incubated at 37 ± 1°C for 3 minutes.
The PTT reagent is then added followed by the addition of a calcium chloride solution which inactivates the anticoagulant and allows a clot to form. The amount of time elapsed prior to the clot formation is monitored and recorded. Evaluation of the clotting times is performed using statistical comparisons to the controls.