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Randox Sodium Test Kit: The Randox Laboratories Ltd. Sodium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Sodium in serum. Sodium is determined enzymatically via Sodium dependant 9-galactosidase activity with ONPG as substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hyper-tension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. This Application Sheet has been developed for the Hitachi 704, 717, 902 and 911/912 Analysers and must be used by suitable qualified laboratory personnel under appropriate laboratory conditions.

Randox Electrolyte Cal 1 and 2: Randox Electrolyte Cal 1 and 2 are liquid calibrators for in vitro diagnostic use in the calibration of NA+, K+ and CL- electrodes on Hitachi systems ISE modules and Randox Enzymatic Sodium kit. The Randox Electrolyte Cal 1 and 2 must only be used by suitable qualified laboratory personnel under appropriate laboratory conditions.

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I am sorry, but the provided text does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device. The document is an FDA 510(k) clearance letter for a "Sodium Test Kit and electrolyte Cal 1 and 2," which discusses the substantial equivalence of the device to existing predicate devices. It outlines the indications for use of the Randox Sodium Test Kit and Randox Electrolyte Cal 1 and 2, but it does not provide the specific performance data or study details you requested.

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