ABL90 FLEX PLUS System

The ABL90 FLEX PLUS System is a portable, automated analyzer that measures glucose levels in heparinized capillary whole blood. It is intended for use by trained healthcare professionals in laboratory, near-patient, or point-of-care settings under a physician's order, and the measurements help diagnose and treat carbohydrate metabolism disorders including diabetes mellitus and hypoglycemia.

The device uses amperometry as its operating principle and includes a sensor cassette and solution pack consumables. It has three different measuring modes: S65 syringe mode, SP65 short probe mode for venous/arterial samples, and C65 mode for capillary samples. The reportable range is 18-738 mg/dL compared to the predicate's 20-700 mg/dL, with a sample volume of 65 µL requiring balanced heparin anticoagulant.

Analytical performance testing was conducted using Clinical Laboratory Standards Institute (CLSI) guidelines, specifically CLSI EP05-A3 for precision evaluation and CLSI EP09c (3rd Edition) for method comparison and bias estimation using patient samples.

The ABL90 FLEX PLUS demonstrates substantial equivalence to the i-STAT G Cartridge with i-STAT 1 System through identical intended use (in vitro glucose quantification in whole blood), same operating principle (amperometry), equivalent sample requirements (65 µL), and acceptable analytical performance with minimal bias across medical decision levels. Precision testing showed acceptable repeatability (CV% 2.5%) and method comparison demonstrated R² values of 0.97-1.00 with negligible bias.