Feasibility Performance Study of ABL90 FLEX PLUS HEM

Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM

This feasibility performance study evaluates the ABL90 FLEX PLUS HEM device for its analytical performance in a clinical setting. The study aims to evaluate the performance of the hemolysis detection feature.

The study is designed to assess the feasibility and performance of the ABL90 FLEX PLUS HEM device in a clinical environment. It will involve testing whole blood samples using the device and comparing results against established reference method. The primary focus is on validating the device's performance of the hemolysis detection function. The study will be conducted at one selected clinical site with trained personnel and will follow a predefined protocol to ensure consistency and reliability of data collection. The outcomes will inform future clinical studies aimed at supporting regulatory submissions and clinical adoption.

Inclusion Criteria:

• Subject must be 18 years of age or older

• Informed consent is obtained:

  • Directly from the subject, if they are competent and able to understand the provided information and voluntarily agree to participate, or
  • If the subject is temporarily incapacitated and unable to provide informed consent at the time of sample collection, written informed consent will be obtained from the subject's legally designated representative (LDR). when the subject regains capacity after enrollment, they will be informed of study inclusion and given the opportunity to withdraw consent.

• Subject evaluated as suitable according to the protocol and for the study by the principal investigator or designee.

Exclusion Criteria:

• Subject where sample collection is evaluated by PI or designee to impose unnecessary risk.
• Subject with an invalid written informed consent or who has withdrawn consent.
• Subject with known pregnancy or who is breastfeeding.