ABL90 FLEX PLUS System, safeCLINITUBES

The ABL90 FLEX PLUS System is a portable, automated blood gas analyzer that measures pCO2 (carbon dioxide) in heparinized arterial, venous, and capillary whole blood, and pH and total hemoglobin (ctHb) in heparinized capillary whole blood. It is intended for use by trained technologists, nurses, physicians, and therapists in laboratory, near-patient, or point-of-care settings to aid in diagnosis and treatment of acid-base disturbances and anemia. safeCLINITUBES are plastic capillary tubes with heparin used to collect, mix, and dispense blood samples for the analyzer.

The ABL90 FLEX PLUS System uses potentiometry for pH and pCO2 measurement and spectrophotometry for total hemoglobin measurement. It features an automated sample inlet mechanism with three measuring modes: S65 syringe mode, SP65 short probe mode, and C65 capillary mode. The device has reportable ranges of pH 6.818–7.797, pCO2 15.4–98.3 mmHg, and ctHb 0.1–24.0 g/dL, with 65 µL sample volume requirements.

Testing was conducted according to CLSI (Clinical Laboratory Standards Institute) guidelines: EP06 for linearity, EP17-A2 for detection capability, EP05-A3 for precision, EP09c for method comparison and bias, EP07 and EP37 for interference testing. All CLSI standards are FDA-recognized consensus standards.

The subject device is substantially equivalent to the predicate ABL90 FLEX PLUS (K160153) because both are made by the same manufacturer, measure the same analytes (pCO2, pH, ctHb) using identical operating principles (potentiometry and spectrophotometry), support the same sample types and modes, have identical reportable ranges and sample volumes, and demonstrated acceptable analytical performance with linearity, precision, and method comparison data comparable to the predicate.