(118 days)
The ATAC Iron Reagent Kit, which contains both reagent and calibrator, is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of total iron in serum. The ATAC TIBC Column Kit, which is marketed with generic labeling and an ATAC 8000 Application Sheet, is intended for use with the ATAC Iron Reagent Kit and other iron reagents for the quantitative determination of total iron binding capacity in serum.
Total iron results are used for the diagnosis and treatment of diciency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, and characterized by pigmentation of the skin), and chronic renal disease. Total iron binding capacity measurements are used for the diagnosis and treatment of anemia.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
The ATAC Iron Reagent measures total serum iron by stripping it from the transferrin in a low pH reagent buffer, oxidizing it to ferric ions and binding it with Ferrozine. The resulting increase in absorbance at 546 nm is proportional to the iron concentration in the sample. The ATAC TIBC Column Kit is used to pretreat serum specimens prior analysis. The iron in the saturating reagent ensures that all available iron binding sites in the serum specimen are saturated with iron. The filtrate is assayed with an iron reagent after removing the unbound iron form the sample mixture by passing it through an alumina column. The maximum amount of iron bound in the specimen is a measure of its transferrin concentration.
The provided document describes the ATAC Iron Reagent Kit and ATAC TIBC Column Kit for quantitative determination of total iron and total iron binding capacity in serum. The study aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study particulars:
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria, but rather presents performance characteristics of the device and claims substantial equivalence to predicate devices. The "reported device performance" are the results of the effectiveness and precision studies.
ATAC Iron Reagent Kit Performance:
| Performance Metric | Reported Device Performance |
|---|---|
| Linearity | 25 to 500 µg/dL |
| Regression Error | 3.1 ug/dL |
| Precision | |
| Serum 1 (67 ug/dL) | Within Run: 2.2% CV |
| Total: 4.3% CV | |
| Serum 2 (177 ug/dL) | Within Run: 1.1% CV |
| Total: 2.5% CV | |
| Serum 3 (282 ug/dL) | Within Run: 1.5% CV |
| Total: 3.0% CV | |
| Method Comparison | ATAC 8000 = 8.8 ug/dL + 0.969 x Competitive Reagent |
| Sy.x | 3.0 µg/dL |
| Range Tested | 31 - 165 ug/dL |
| Stability |
§ 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.