(150 days)
The Vitalab Iron Reagent Kit, which contains both reagent and calibrator, is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of total iron in serum and plasma. Iron results may be used for the diagnosis and treatment of diseases associated with iron metabolism such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
The Vitalab Iron Reagent Kit and the Vitalab Selectra Analyzer are used as a system for the quantitative determination of total iron in serum and plasma. Iron in the sample is specifically released from transferrin using an acidic buffer. The released iron is then reduced and reacts with a chromogenic indicator. The increase in absorbance at 578 nm is measured photometrically. The increase in absorbance at 578 nm is proportional to the iron concentration of the sample.
The provided text describes the acceptance criteria and study for the Vitalab Iron Reagent Kit and Vitalab Selectra Analyzer, which are used as a system for the quantitative determination of total iron in serum and plasma.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity | Good linear relationship (regression statistics) | (Vitalab Recoveries) = 0 ug/dL + 1.017 x (Concentration), n = 44 |
| Precision (Within Run) - Serum 1 (57 ug/dL) | Not explicitly stated but typically low CV% | 1SD = 0.9, %CV = 1.6% |
| Precision (Within Run) - Serum 2 (158 ug/dL) | Not explicitly stated but typically low CV% | 1SD = 0.9, %CV = 0.6% |
| Precision (Within Run) - Serum 3 (260 ug/dL) | Not explicitly stated but typically low CV% | 1SD = 1.0, %CV = 0.4% |
| Precision (Total) - Serum 1 (57 ug/dL) | Not explicitly stated but typically low CV% | 1SD = 1.5, %CV = 2.7% |
| Precision (Total) - Serum 2 (158 ug/dL) | Not explicitly stated but typically low CV% | 1SD = 3.0, %CV = 1.9% |
| Precision (Total) - Serum 3 (260 ug/dL) | Not explicitly stated but typically low CV% | 1SD = 5.2, %CV = 2.0% |
| Method Comparison with Competitive Reagent | Good correlation and agreement | Selectra = 1.1 µg/dL + 0.988 x Competitive Reagent |
| Method Comparison (Deming Statistics) | Not explicitly stated but typically small bias/error | s(y.x) = 2.3 µg/dL |
| Detection Limit (Claimed) | Documented | 8.2 µg/dL iron (based on observed standard deviation of 2.8 µg/dL) |
| Onboard Reagent Stability | Less than 2% coefficient of variation (CV%) after 14 days | All cases: statistical estimates of CV |
§ 862.1410 Iron (non-heme) test system.
(a)
Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.(b)
Classification. Class I (general 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.