(149 days)
The Sekisui Magnesium Assay is for the quantitative determination of magnesium in human serum and plasma (Lithium Heparin) on automated chemistry analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only.
The Sekisui Magnesium assay kit consists of the following: Magnesium Reagent: A solution containing buffer (pH 11.2 at 25°C), 0.14 mmol/L xylidy/ blue-1, 0.1 mmol/L EGTÅ, and a surfactant.
Here's a breakdown of the acceptance criteria and the study information for the Sekisui Magnesium Assay, based on the provided text:
Acceptance Criteria and Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from Study Design) | Reported Device Performance (Sekisui Magnesium Assay) |
|---|---|---|
| Precision | Total CV%: | |
| 0.8 mg/dL (low) | N/A (evaluated per CLSI EP5-A2) | 6.1% |
| 2.0 mg/dL (mid) | N/A (evaluated per CLSI EP5-A2) | 3.7% |
| 4.7 mg/dL (high) | N/A (evaluated per CLSI EP5-A2) | 3.2% |
| Within Run CV%: | ||
| 0.9 mg/dL (low) | N/A (evaluated per CLSI EP5-A2) | 7.0% |
| 2.0 mg/dL (mid) | N/A (evaluated per CLSI EP5-A2) | 2.2% |
| 4.9 mg/dL (high) | N/A (evaluated per CLSI EP5-A2) | 1.6% |
| Linearity / Reportable Range | Demonstrably linear over the specified range for a linear equation (Nonlinearity |
§ 862.1495 Magnesium test system.
(a)
Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).(b)
Classification. Class I.