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The Randox Laboratories Ltd. Potassium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Potassium in serum. Potassium is determined enzymatically via Potassium dependant pyruvate kinase activity using phosphoenolpyruvate as substrate. The pyruvate formed reacts with NADH in the presence of LDH to form lactate and NAD. The corresponding decrease in absorbance at 340 nm is proportional to the potassium concentration.

Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

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 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 Potassium 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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The provided text is a 510(k) premarket notification letter from the FDA to Randox Laboratories Ltd. for a "Potassium Test Kit and Electrolyte Cal 1 and 2". It does not contain the detailed information necessary to answer the questions about acceptance criteria and a definitive study demonstrating the device meets those criteria.

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or the ground truth used for testing.
• Details on the training set or how its ground truth was established.

The "Indications for Use" section (page 2) describes what the device does and some technical details of its operation (enzymatic method for potassium determination, compatible analyzers), but it does not specify performance metrics or acceptance criteria for those metrics. The letter focuses on regulatory clearance based on substantial equivalence, not on a detailed scientific study report.

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