(149 days)
Tosoh AIA-PACK RBC FOLATE is designed for in vitro diagnostic use only for the quantitative measurement of red blood cell folate (RBC FOLATE) in whole blood (Heparin or EDTA) samples on TOSOH AIA system analyzer. Measurement of RBC Folate is used in the diagnosis and treatment of anemia.
The Tosoh AIA-PACK RBC FOLATE is a competitive enzyme immunoassay which, after sample hemolysis and sample pretreatment, is performed entirely within the AIA-PACK. First, sample hemolysis is performed to achieve complete hemolysis of erythrocytes and deconjugation to monoglutamate in the whole blood sample using sample hemolyzing reagents (containing ascorbic acid). After sample hemolysis, sample pretreatment is performed to release folate from endogenous binding proteins in the hemolysate sample using sample pretreatment reagents (containing sodium hydroxide and dithiothreitol). Folate present in the pretreated test sample competes with enzyme-labeled folate for a limited number of binding sites on a fluorescein labeled bovine folate binding protein which then binds to anti-FITC (fluorescein isothiocyanate) antibody immobilized on magnetic beads. The beads are washed to remove the unbound enzyme-labeled folate and are then incubated with a fluorogenic substrate, 4-methylumbelifery| phosphate (4MUP). The amount of enzyme labeled folate that binds to the beads is inversely proportional to the folate concentration in the test sample. A standard curve using a range of known standard concentrations is constructed and unknown folate concentrations are calculated using this curve.
The Tosoh AIA-PACK RBC FOLATE is a device designed for the quantitative measurement of red blood cell folate (RBC FOLATE) in whole blood samples, used in the diagnosis and treatment of anemia. The device's performance was evaluated through various studies to demonstrate substantial equivalence to a predicate device (Bayer K010050, ADVIA Centaur and ACS: 180 Folate Immunoassay).
The document provides performance data for several criteria: Recovery, Dilution, Linearity, Precision, Correlation, Specificity, and Limit of Detection (LoD)/Limit of Quantitation (LoQ). Acceptance criteria are not explicitly stated as distinct numerical targets but are implied by the reported performance and the overall conclusion of substantial equivalence based on established CLSI protocols.
Here's a breakdown of the acceptance criteria and the study results:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied by CLSI Protocols and Performance) | Reported Device Performance |
|---|---|---|---|
| Recovery | Percent Recovery | Generally 90-110% (standard for spiked recovery studies) | Ranged from 94.2% to 102.7% (demonstrated good recovery) |
| Dilution | Percent Recovery (after serial dilution) | Generally 90-110% (standard for dilution linearity studies) | Ranged from 100.0% to 114.7% (demonstrated good linearity upon dilution) |
| Linearity | Linear range with ±10% difference | Linear from 0.5 to 40.0 ng/mL, within ±10% | Demonstrated linearity from 0.5 to 40.0 ng/mL, within ±10% difference. The claimed linearity was 0.62 to 24.0 ng/mL. |
| Precision | Within-run CV (%) | Typically 0.95 for strong correlation | 0.99 |
| Slope (Deming Regression) | Close to 1 (e.g., 0.9-1.1) | 0.959 (0.922 to 0.996) | |
| Y-intercept (Deming Regression) | Close to 0 | - 3.890 (-13.512 to 5.732) | |
| Correlation (vs. Alternate Method) | Correlation Coefficient (r) | Typically > 0.90 for good correlation | 0.87 (Deming Regression), 0.86 (Linear Regression with hematocrit correction) |
| Slope (Deming Regression) | Close to 1 (e.g., 0.9-1.1) | 1.06 (0.950 to 1.168), 1.00 (0.897 to 1.107 with hematocrit correction) | |
| Y-intercept (Deming Regression) | Close to 0 | -19.554 (-44.640 to 5.532), -26.60 (with hematocrit correction) | |
| Specificity | Cross-reactivity (%) for common interferences | Low percentage (e.g., |
§ 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.