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EML105 is a stand alone, electrolyte metabolite analyzer that measures Na , K+, Ca2+, CI, glucose and lactate on whole blood and urine. It can be interfaced with an ABL analyzer 500/510/520 to become an ABL System 605/615/625 for the measurement of pH/Blood gases, electrolytes, metabolites and co-oximetry.

EML105 is an automated electrolyte metabolite analyzer that is 40 cm x 35 cm x 40 cm (WHD) and weighs 22 kg. It measures on whole blood and urine in approximately 54 seconds.

This document is a 510(k) summary for a medical device called EML105, an electrolyte metabolite analyzer. It describes the device, its intended use, and claims substantial equivalence to a previously marketed device (EML105) and a predicate device (YSI 2300) for the new lactate analyte.

However, the provided text does not contain any information regarding acceptance criteria, study methodologies, device performance data, sample sizes, ground truth establishment, or expert involvement. It is solely a regulatory submission summary outlining the device's characteristics and its predicate devices.

Therefore, I cannot provide the requested information in the format specified. The document lacks the detailed study results and performance metrics needed to answer your questions.

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