(265 days)
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, lithium heparin plasma, and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
Folate levels in serum, lithium heparin plasma, and red blood cells are used to assess folate status. The serum folate levels is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency.
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum and lithium heparin plasma or red blood cells using the Access Immunoassay Systems.
The provided text describes the Beckman Coulter Access Folate Assay, a chemiluminescent immunoassay for the quantitative determination of folic acid levels. The submission is a 510(k) premarket notification for demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and supporting studies based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison | R² ≥ 0.90 and slope 1.00 ± 0.12. Estimated bias at concentration corresponding to reference limits suggestive that values have not changed appreciably. | R² = 0.99, Slope = 1.04 (95% CI: 1.01 - 1.07), Intercept = 0.081 (95% CI: -0.074 - 0.19). The study met the acceptance criteria. The estimated bias at concentration corresponding to reference limits defined on the predicate system suggest that such values have not changed appreciably on the DxI 9000 analyzer. |
| Linearity | Linear throughout the analytical measuring interval (2.0 - 24.8 ng/mL). | The study met the acceptance criterion, indicating linearity on the DxI 9000 Immunoassay Analyzer throughout the analytical measuring interval (2.0 - 24.8 ng/mL). |
| Serum Imprecision | Not explicitly stated as acceptance criteria, but based on typical standards for imprecision: Expected low %CV for higher concentrations and low SD for lower concentrations. | Within-laboratory (total) % CV: between 2.2% and 4.4% for Folate concentrations > 2.0 ng/mL. Within-laboratory (total) SD: between 0.10 - 0.21 for Folate concentrations ≤ 2.0 ng/mL. Repeatability (within-run) % CV: between 1.6% and 2.7% for Folate concentrations > 2.0 ng/mL. Repeatability (within-run) SD: between 0.08 - 0.09 for Folate concentrations ≤ 2.0 ng/mL. |
| RBC Imprecision | Not explicitly stated as acceptance criteria, but based on typical standards for imprecision: Expected low %CV. | Within-laboratory (total) % CV: ranged from 1.9% to 4.9%. |
| Limit of Blank (LoB) | Claimed LoB of 0.80 ng/mL (1.81 nmol/L). | The assay is designed to meet the claimed LoB of 0.80 ng/mL. |
| Limit of Detection (LoD) | Claimed LoD of 1.0 ng/mL (2.27 nmol/L). | The assay is designed to meet the claimed LoD of 1.0 ng/mL. |
| Limit of Quantitation (LoQ) | Claimed LoQ of |
§ 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.