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Reagent for the determination of cholinesterase concentrations in human serum and plasma using the Olympus family of clinical chemistry analyzers.

Measurement of serum cholinesterase has been used to assess liver function and to investigate the variants of cholinesterase enzyme. It is also useful in predicting susceptibility to prolonged apnea after the administration of succinylcholine and in monitoring excessive exposure to organophosphorus insecticides.

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Please provide the full study report or 510(k) submission for the Olympus Cholinesterase Reagent (K030045).

The provided text is an FDA clearance letter and an "Indications for Use Statement." These documents confirm that the device has been cleared for market and state its intended use, but they do not contain the detailed study information or acceptance criteria needed to answer your questions.

Specifically, the clearance letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device's performance was compared to a predicate device, but the details of that comparison, including acceptance criteria and the study design, are not present in these documents.

To answer your questions accurately, I would need a document like the "510(k) Premarket Notification" itself, or a detailed study report that describes the validation studies performed for the Olympus Cholinesterase Reagent.

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