(308 days)
(1) Elecsys Folate III: Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias. For in vitro diagnostic use.
(2) Elecsys RBC Folate Hemolyzing Reagent: Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate III assay for the quantitative determination of folate in erthrocytes (RBC (red blood cell) folate). Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias.
(3) Elecsys Folate III CalSet: Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.
(4) Elecsys Folate III CalCheck: Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
(5) Elecsys PreciControl Anemia: Elecsys PreciControl Anemia is used for the quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
(1) The Elecsys Folate III assay employs a competitive test principle using natural folate binding protein (FBP) specific for folate. Folate in the sample competes with the added folate (labeled with biotin) for the binding sites on FBP (labeled with ruthenium complex). Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.
(2) The Elecsys RBC Folate Hemolyzing Reagent is a 0.2% ascorbic acid solution with which whole blood treated with anticoagulants (heparin or EDTA) is diluted. After incubation the erythrocytes are lysed and intracellular folate is liberated and stabilized. The hemolysate is then used as a prediluted sample for subsequent measurement in the Elecsys Folate III assay.
(3) The Elecsys Folate III CalSet is a lyophilized product consisting of human serum with folic acid in two concentration ranges. During manufacture, the analyte is spiked into the matrix. This calibrator is used to calibrate the Elecsys Folate III assay.
(4) Elecsys Folate III CalCheck is a lyophilized product consisting of human serum with folic acid. During manufacture, the analyte is spiked into the matrix. This solution is used to verify the calibration established with the Elecsys Folate III CalSet.
(5) The Elecsys PreciControl Anemia is a lyophilized control serum based on human serum matrix in three concentration ranges. The controls are used for monitoring the accuracy and precision of the Elecsys Ferritin, Folate III, and Vitamin B12 immunoassays.
The Elecsys Folate III Test System, including Elecsys Folate III, Elecsys RBC Folate Hemolyzing Reagent, Elecsys Folate III CalSet, Elecsys Folate III CalCheck, and Elecsys PreciControl Anemia, is designed for the in vitro quantitative determination of folate in human serum, plasma, and erythrocytes. This system is intended for use in the diagnosis and treatment of anemias on Elecsys and cobas e immunoassay analyzers.
The acceptance criteria for the Elecsys Folate III and Elecsys RBC Folate Hemolyzing Reagent assays were established through comparison studies against their respective predicate devices (Elecsys Folate II Assay and Elecsys RBC Folate Hemolyzing Reagent (K051292)). The primary method for proving the device meets these criteria is through Method Comparison studies using Passing-Bablok and Linear Regression analysis.
Here's the breakdown of the acceptance criteria and performance:
| Acceptance Criteria Category | Acceptance Criteria (Predicate Device) | Reported Device Performance (Elecsys Folate III) |
|---|---|---|
| Elecsys Folate III Assay | ||
| Measuring Range | 0.600 - 20.00 ng/mL | 1.5 - 20.0 ng/mL |
| Precision (Total CV for Human Samples 10 ng/mL) | 7.0% | 5.0% |
| Analytical Sensitivity (Lower Detection Limit) | 0.6 ng/mL | Limit of Detection = ≤1.5 ng/mL |
| Interferences (Icterus) | recovery within ± 10% of initial value for bilirubin |
§ 862.1295 Folic acid test system.
(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.