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The Randox Laboratories Limited Inorganic Phosphorous Test Kit is an in vitro diagnostic reagent for the quantitative determination of inorganic phosphorous in serum. The method is based on the interaction of inorganic phosphorous with ammonium-molybdate in the presence of sulphuric acid to form a phosphomolybdate complex which is measured at 340nm. Measurements of inorganic phosphorous are used in the diagnosis and treatment of various disorders including, renal failure, hyper- and hypoparathyroidism and vitamin D deficiency. This test kit must be used by suitably qualified laboratory personnel, under appropriate laboratory conditions.

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This document is a 510(k) clearance letter from the FDA for a medical device, the "Randox Inorganic Phosphorous Test Kit." It is not a study report and therefore does not contain the detailed information requested about acceptance criteria, study design, or performance metrics.

The document does not provide the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about training sets.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Details on standalone algorithm performance.
• Specifics about the type of ground truth used (beyond implying a chemical reaction based on known inorganic phosphorous).

The document's purpose is to state that the FDA has reviewed the manufacturer's submission and determined the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It describes the intended use of the device: "The Randox Laboratories Limited Inorganic Phosphorous Test Kit is an in vitro diagnostic reagent for the quantitative determination of inorganic phosphorous in serum." It also briefly explains the methodology: "The method is based on the interaction of inorganic phosphorous with ammonium-molybdate in the presence of sulphuric acid to form a phosphomolybdate complex which is measured at 340nm."

To obtain the detailed information requested, one would need to review the original 510(k) submission (K974605) filed by Randox Laboratories, Ltd. to the FDA, which would contain the performance data and methodology used to demonstrate substantial equivalence.

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