(10 days)
The Vitalab Magnesium Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results may be used for the diagnosis and treatment of hypomagnesemia (abnomally low plasma levels of magnesium) and hypermagnesemia (abnomally high plasma levels of magnesium).
The Vitalab Magnesium Reagent is a single-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines magnesium through chelation by xylidyl blue producing a colored complex.
Here's a breakdown of the acceptance criteria and study information for the Vitalab Magnesium Reagent, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Linear Range | 0.1 to at least 5.0 mg/dL |
| (Vitalab Recoveries) = 0 mg/dL + 0.883 x (Reference), r = 0.997, sxx = 0.10 mg/dL, n = 55 | |
| Detection Limit | 0.1 mg/dL (calculated as mean + 2 standard deviations from 30 assays of normal saline, rounded up) |
| Precision | Serum 1 (1.2 mg/dL): Within Run 1SD = 0.03, %CV = 2.2%; Total 1SD = 0.4, %CV = 3.2% |
| Serum 2 (2.2 mg/dL): Within Run 1SD = 0.02, %CV = 0.8%; Total 1SD = 0.3, %CV = 1.1% | |
| Serum 3 (3.3 mg/dL): Within Run 1SD = 0.02, %CV = 0.7%; Total 1SD = 0.3, %CV = 1.0% | |
| Correlation | Selectra = 0.3 mg/dL + 0.889 x Competitive Reagent, syx = 0.04 mg/dL (range = 1.5 - 5.2 mg/dL, n = 118) |
| Stability | 14-day onboard reagent stability (total imprecision |
§ 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.