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For the quantitative determination of inorganic phosphorus in serum. For IN VITRO diagnostic use. Increased serum inorganic phosphorus levels (hyperphosphatemia) are usually the result of Vitamin D overdose, hypoparathyroidism, or renal failure. Decreased serum levels (hypophosphotemia) usually result from rickets, hyperparathyroidism, or Fanconi Syndrome (a defect in absorption of phosphorus and other metabolites from the glomerular filtrate). (1)

The majority of methods for determining inorganic phosphorus are based on the reduction of a phosphorus-molybdate complex with a reducing agent resulting in the subsequent formation of molybdenum blue. In 1972, Daly and Ertingshausen introduced a method for inorganic phosphorus which measured the unreduced phosphorus-molybdate complex. This procedure is a modification of the Daly and Ertingshausen technique (2).

The provided text is a letter from the FDA regarding a 510(k) clearance for a device called "Phosphorus-SL Assay." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance tables, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document specifically mentions:

• Device Name: Phosphorus-SL Assay
• Indications for Use: For the quantitative determination of inorganic phosphorus in serum. For IN VITRO diagnostic use. Increased serum inorganic phosphorus levels (hyperphosphatemia) are usually the result of Vitamin D overdose, hypoparathyroidism, or renal failure. Decreased serum levels (hypophosphotemia) usually result from rickets, hyperparathyroidism, or Fanconi Syndrome (a defect in absorption of phosphorus and other metabolites from the glomerular filtrate).
• Methodology: The majority of methods for determining inorganic phosphorus are based on the reduction of a phosphorus-molybdate complex with a reducing agent resulting in the subsequent formation of molybdenum blue. In 1972, Daly and Ertingshausen introduced a method for inorganic phosphorus which measured the unreduced phosphorus-molybdate complex. This procedure is a modification of the Daly and Ertingshausen technique.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and study information because that information is not present in the provided text. The document is solely a regulatory clearance letter, not a detailed study report.

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