ABL90 FLEX PLUS System

The ABL90 FLEX PLUS System is a portable, automated blood analyzer that measures electrolytes (potassium, sodium, calcium), glucose, and lactate in heparinized whole blood samples. It is intended for use by trained technologists, nurses, physicians, and therapists in laboratory, point-of-care, or near-patient settings under physician order.

The device uses potentiometry for electrolyte measurement and amperometry for glucose and lactate measurement. It features a touch screen, barcode reader, sample mixer, inlet module with two sampling modes (S65 syringe and SP65 short probe), fluid transport system, oximetry module, and optional battery pack. Compared to the ABL90 FLEX predicate, the PLUS version maintains the same operating principles, major components, and consumables (sensor cassette and solution pack), with slightly expanded reportable ranges for calcium (up to 9.94 mg/dL versus 9.92 mg/dL) and glucose (starting at 18 mg/dL versus 9 mg/dL).

Testing followed Clinical Laboratory Standards Institute (CLSI) guidelines including EP06 (linearity), EP17-A2 (detection capability), EP05-A3 (precision), EP09c (method comparison and bias), EP07 (interference testing), and EP37 (supplemental interference tables). All cited CLSI standards are FDA-recognized consensus standards.

The ABL90 FLEX PLUS is substantially equivalent to the ABL90 FLEX predicate because both devices measure the same analytes using identical operating principles (potentiometry and amperometry), target the same intended users and settings, accept the same sample types and volumes with balanced heparin anticoagulant, and share the same major components and consumables. The PLUS model demonstrates acceptable analytical performance across linearity, precision, accuracy (method comparison), and interference testing with results comparable to or better than the predicate. The minor differences in reportable ranges are within acceptable analytical variation and do not affect clinical utility.