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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:

ATAC TIBC Column Kit Performance:

2. Sample Size and Data Provenance (Test Set):

• ATAC Iron Reagent Kit Method Comparison: n = 58 serum specimens.
• ATAC TIBC Column Kit Method Comparison: n = 55 serum specimens.
• Data Provenance: Serum specimens were collected from adult patients. No specific country of origin is mentioned. The studies appear to be prospective, collecting and analyzing patient samples.

3. Number of Experts and Qualifications (Ground Truth for Test Set):

Not applicable. This device is an in-vitro diagnostic assay. The "ground truth" for the test set is established by a "commercially available method" (predicate device), not by expert human interpretation.

4. Adjudication Method (Test Set):

Not applicable for this type of in-vitro diagnostic device. The comparison is between the new device and a predicate device, using objective quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human reading is involved (e.g., radiology images). This device is a quantitative assay.

6. Standalone Performance Study:

Yes, standalone performance studies were conducted. The "effectiveness" studies for both the ATAC Iron Reagent Kit and the ATAC TIBC Column Kit describe the performance of the device itself (linearity, precision) and its correlation with a comparative method. This demonstrates the algorithm-only performance, as it's a quantitative chemical assay.

7. Type of Ground Truth Used:

The ground truth for comparison in the method comparison studies was established by another "commercially available method" (i.e., the predicate device) for both total iron and TIBC. This is a common approach for demonstrating substantial equivalence for in-vitro diagnostic devices.

8. Sample Size for the Training Set:

Not explicitly stated. For "linearity" studies, it mentions "linearity standards that span the usable range" (for Iron Reagent) and "diluted serum pools that span the usable range" (for TIBC). For "precision" studies, it mentions "replicate assay of commercially available control serum" (n=60 for each of three serum levels for iron, and n=60 for each of two serum levels for TIBC). These are more akin to calibration and verification samples rather than a "training set" in the machine learning sense. This device is a chemical reagent kit, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not explicitly stated regarding a "training set" in the machine learning context. For the linearity and precision studies, the "ground truth" or reference values are inherent in the linearity standards and commercially available control serums used, whose concentrations would have been established by reference methods or manufacturer's assays.

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