Change in supply chain challenges and the need to manufacture the PICO A and safePICO A syringes, which the study was designed to validate, is no longer required.

The purpose is to determine the in-use stability of 17 parameters (pH, pCO2, pO2, cNa+, cCa2+, cCl-, cK+, cGlu, cLac, ctHb, sO2, FMetHb, FCOHb, FO2Hb, FHHb, FHbF & ctBil) in adult arterial and venous whole blood drawn and stored in aspirating syringes (PICO A and safePICO A) measured on ABL90 FLEX PLUS analyzer.

The study aims to determine the in-use sample stability for up to 45 min at room temperature (18-25 °C) for arterial and venous blood sample analysis in the PICO A and safePICO A syringes for all 17 parameters.

In-use analyte stability study for 17 parameters. The stability study is a 5 time-point study analyzing five (5) syringes at T = 0 min, 10 min, 20 min, 30 min and 45 min. after sample collection. Series of five (5) syringes are collected from each investigational device safePICO A and PICO A. Each type of syringe will be analyzed on one ABL90 Flex Plus analyzer and for both types of blood (Arterial or Venous). For each syringe type a minimum of 50 + 7 series (7 contrived series) with samples within the reportable ranges will need to be tested for each blood type.

Inclusion Criteria:

Subjects must meet all the criteria listed below to be eligible for participation in the study.

1. Subject must be 18 years of age or older.
2. Subject must have an arterial and/or venous line established as a part of the standard of care.
3. Subject evaluated by the principal investigator or designee as suitable for the study according to the protocol.

Exclusion Criteria:

Subjects meeting any of the criteria listed below will not be eligible for participation in the study.

1. Subjects, who are pregnant or breastfeeding.

2. Subjects who have been previously enrolled into this study.

3. Subjects exposed to following substances within the last 72 hours:

   • Acetylsalicylic Acid Sodium Salt at dose equal or above 1 gram/day
   • Acetylcysteine
   • Fluorescein dye
   • Patent Blue dye

Adult patients 18 years or older, critically ill, but still able to understand and sign the informed consent form and admitted to the hospital having an arterial catheter line established as part of standard of care to minimize the risk to the patient when having blood samples drawn.

To reach reportable concentrations of the 17 parameters covering the reportable range as much as possible the subject will be a patient in the intensive care unit or another unit corresponding to the emergency care.