(120 days)
OLYMPUS System reagent for the quantitative determination of calcium concentrations in human serum, plasma and urine on OLYMPUS analyzers.
Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Olympus Calcium Arsenazo Reagent
This is a 510(k) clearance letter for the Olympus Calcium Arsenazo Reagent, a calcium test system. This document grants market clearance based on substantial equivalence to a predicate device, not on specific performance data and acceptance criteria detailed in the letter itself. Therefore, the requested information regarding acceptance criteria and the study proving the device meets them, including sample sizes, expert details, adjudication methods, and MRMC/standalone studies, cannot be found in the provided text.
The document only states the device's indications for use: "OLYMPUS System reagent for the quantitative determination of calcium concentrations in human serum, plasma and urine on OLYMPUS analyzers. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms)."
To obtain the detailed study information, one would typically need access to the full 510(k) submission, which is not provided here.
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.