ABL90 FLEX PLUS System

The ABL90 FLEX PLUS System is a portable, automated in vitro diagnostic analyzer that quantitatively measures electrolytes (chloride, sodium, and calcium) in heparinized whole blood samples. It is intended for use by trained healthcare professionals in laboratory, near-patient, or point-of-care settings under a physician's order for diagnosis and treatment of electrolyte and metabolic disorders.

The ABL90 FLEX PLUS uses potentiometry operating principles with a sensor cassette and solution pack consumables, processes smaller sample volumes (65 µL vs. 135 µL), and includes three automated sampling modes (S65 syringe, SP65 short probe for arterial/venous, and C65 for capillary). The reportable ranges are cNa+: 116-180 mEq/L, cCl−: 86-151 mEq/L, and cCa2+: 2-9.94 mg/dL, with a linearity interval of 70.1-165.0 mEq/L for chloride.

Testing was conducted in general accordance with FDA-recognized CLSI standards including EP06 (linearity), EP17-A2 (detection capability), EP05-A3 (precision), EP07 (interference testing), and EP39 (surrogate sample selection). All analytical performance testing evaluated linearity, limit of blank, detection and quantification, precision, bias, interference, and stability.

The ABL90 FLEX PLUS is substantially equivalent to the Stat Profile Prime Plus Analyzer System predicate (K200403) because both measure the same electrolytes using potentiometry in similar clinical settings, share identical product codes and regulatory classification, and demonstrate acceptable analytical performance with comparable operating principles and intended use despite minor differences in sample volume and modes.