(140 days)
Binding assay for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Folic acid measurements are used in the diagnosis and treatment of anemias.
The 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 a ruthenium complex). Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code.
Roche Diagnostics' Elecsys Folate III Assay is a quantitative in vitro diagnostic device designed for measuring folate levels in human serum, primarily for the diagnosis and treatment of anemias. The following outlines its acceptance criteria and the studies performed to demonstrate its performance.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Elecsys Folate III Assay are primarily established through comparison to a predicate device, the Roche Elecsys Folate III (K082340). The device demonstrates comparable or improved analytical performance characteristics.
| Feature | Predicate Device: Roche Elecsys Folate III (K082340) | Candidate Device: Elecsys Folate III Assay | Acceptance Criteria (Implied by equivalence) |
|---|---|---|---|
| Measuring Range | 1.50 - 20.0 ng/mL | 2.0 - 20.0 ng/mL | Similar or improved range |
| Analytical Sensitivity | |||
| Limit of Blank (LoB) | 0.640 ng/mL | 0.6 ng/mL | Equal to or lower than predicate |
| Limit of Detection (LoD) | 1.50 ng/mL | 1.2 ng/mL | Equal to or lower than predicate |
| Limit of Quantitation (LoQ) | 2.0 ng/mL | 2.0 ng/mL | Equal to or lower than predicate |
| Analytical Specificity (Cross-reactivity) | |||
| Amethopterin | 2.3% at 750 ng/mL | 2.5% at 1500 ng/mL | Comparable or improved |
| Aminopterin | 2.7% at 750 ng/mL | 4.4% at 1500 ng/mL | Comparable or improved |
| Folonic acid | 2.3% at 750 ng/mL | 0.7% at 1500 ng/mL | Comparable or improved |
| Precision (cobas e 411) | |||
| Within-run (Repeatability) | %CV range: 3.7% - 5.8% | %CV range: 2.2% - 6.8% | Comparable to predicate |
| Total (Intermediate) | %CV range: 6.1% - 9.4% | %CV range: 3.7% - 10.8% | Comparable to predicate |
| Limitations (Interference) | |||
| Bilirubin | unaffected |
§ 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.