(117 days)
The N Latex sTfR Reagent is an in vitro diagnostic reagent for the quantitative determination of sTfR in human serum or heparinized plasma using the Behring Nephelometer Systems (BNA, BN100, & BNII), and aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
N Latex sTfR Reagent is intended to be used together with the Behring Nephelometer Systems for the quantitative determination of soluble transferrin receptor (sTfR) in human serum or heparinized human plasma.
Here's a breakdown of the acceptance criteria and study information for the Dade Behring Inc. N Latex sTfR Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the N Latex sTfR Reagent primarily focuses on establishing substantial equivalence to a predicate device rather than defining new, explicit acceptance criteria in the traditional sense. The performance characteristics described are used to demonstrate that the device performs comparably to the predicate. Therefore, the "acceptance criteria" can be inferred from what the manufacturer chose to report as sufficient for equivalence.
| Performance Characteristic | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (N Latex sTfR Reagent) |
|---|---|---|
| Correlation | Strong positive correlation (e.g., r > 0.90) with the predicate device. | r = 0.96 with a commercially available sTfR assay. |
| Slope (Correlation) | Close to 1.0 (indicating similar overall scale). | 0.81 |
| Y-intercept (Correlation) | Close to 0 (indicating similar bias at low concentrations). | -0.19 |
| Inter-assay Precision | Low variability (e.g., |
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).