(441 days)
The Dimension Vista® Magnesium Flex® reagent cartridge (MG) method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista® System. 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).
The Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL) is an in vitro diagnostic product for the calibration of Blood Urea Nitrogen (BUN),Calcium (CA), Cholesterol (CHOL), Creatinine (CRENCRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU) and Uric Acid (URCA) methods on the Dimension Vista® System.
CHEM 1 CAL is a liquid, frozen multi-analyte, bovine serum albumin based product used to calibrate blood urea nitrogen, calcium, cholesterol, creatinine, glucose, lactic acid, magnesium, thyroxine, thyronine uptake and uric acid. The kit consists of six vials, three vials of Calibrator A and three vials of Calibrator B.
The Dimension Vista® MG Flex® reagent cartridge uses a modified methylthymol blue (MTB) complexometric technique. MTB forms a blue complex with magnesium. Calcium interference is minimized by forming a complex between calcium and Ba-EGTA (chelating agent). The amount of MG-MTB complex formed is proportional to the magnesium concentration and is measured using a bichromatic (600 and 510 nm) endpoint technique.
The provided text describes the performance characteristics of the Dimension Vista® Magnesium Flex® reagent cartridge (MG) and the Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL). The focus is on demonstrating substantial equivalence to predicate devices and meeting established clinical laboratory guidelines. However, the information is primarily focused on analytical performance rather than clinical effectiveness or diagnostic accuracy in specific patient populations.
Here's an attempt to extract the requested information, acknowledging that some categories may not be directly applicable or fully detailed given the nature of an in vitro diagnostic device's analytical validation.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Dimension Vista® Magnesium Flex® reagent cartridge (MG) for quantitative measurement of magnesium.
| Performance Characteristic | Acceptance Criteria (Implicit from CLSI Guidelines and Study Design) | Reported Device Performance (MG Assay) |
|---|---|---|
| Method Comparison (Correlation) | High correlation (e.g., r > 0.975) with a legally marketed device; slope close to 1, intercept close to 0. | Serum: Slope: 1.10, Intercept: -0.15 mg/dL, Correlation Coefficient: 1.00 (vs. Beckman AU Magnesium assay) |
| Lithium Heparin Plasma: Slope: 1.05, Intercept: -0.01 mg/dL, Correlation Coefficient: 0.994 (vs. Beckman AU Magnesium assay) | ||
| Urine: Slope: 1.05, Intercept: 0.09 mg/dL, Correlation Coefficient: 0.995 (vs. Beckman AU Magnesium assay) | ||
| Precision (Repeatability & Within-Lab CV%) | Low Coefficient of Variation (CV%) as per CLSI EP05-A2. (Specific numerical criteria are not explicitly stated, but typical ranges for clinical assays are often |
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.