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The ABL835 FLEX analyzer is intended for: in vitro testing of pleural fluid samples for the pH parameter. The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions. Critical values: pH >7.3 is measured in uncomplicated parapneumonic effusions. All pleural effusions with a pH of

ABL835/ABL830/ABL825/ABL820/ABL815/ABL810/ABL805 FLEX analyzers are several models of the same analyzer for the measurement of blood gas, pH, electrolyte, metabolite, cooximetry, and expired air for the parameters p02 and pCO2. An additional indication, namely the measurement of pH in pleura fluids, has been introduced for the ABL835 FLEX analyzer. This additional indication is based on a further development of the software used in all ABL800 FLEX (and ABL700 before that).

Here's an analysis of the provided text regarding the ABL835 FLEX analyzer and its acceptance criteria, structured to answer your questions:

The provided document describes the Radiometer ABL835 FLEX analyzer, specifically focusing on the new indication for measuring pH in pleural fluids. The acceptance criteria and performance studies are presented to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The direct acceptance criteria values are not explicitly stated in a threshold format (e.g., "bias must be

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