(65 days)
The Nichols Advantage Aldosterone Assay is intended for in vitro diagnostic laboratory use with the Nichols Advantage® Specialty System for quantitative measurement of aldosterone in human serum, EDTA plasma, and extracted urine. Aldosterone measurements are intended for use in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.
The Nichols Advantage® Aldosterone Assay is a competitive immunochemiluminometric in vitro diagnostic laboratory immunoassay (IVD device) that utilizes a biotinylated mouse monoclonal anti-aldosterone antibody as the capture reagent and an acridinium ester labeled aldosterone as a tracer reagent. This Aldosterone IVD device immunoassay is intended for use for the measurement of aldosterone in human serum, EDTA plasma, and extracted urine, as an extended diagnostic method utilized within the Nichols Advantage® Specialty System.
Here's an analysis of the provided text regarding the Nichols Advantage® Aldosterone Assay, focusing on acceptance criteria and study details:
Acceptance Criteria and Device Performance
The submission doesn't explicitly state quantitative acceptance criteria in a dedicated section. Instead, the performance characteristics are presented as evidence of the device's capabilities and are implicitly compared to the predicate device or general laboratory expectations. The method comparison to a predicate device serves as the primary "acceptance criterion" for demonstrating substantial equivalence.
Implicit Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implicit / Contextual) | Reported Device Performance (Nichols Advantage® Aldosterone Assay) | Predicate Device (DSL-8600 ACTIVE® Aldosterone Coated-Tube Radioimmunoassay Kit) |
|---|---|---|---|
| Method Comparison (Urine) | |||
| Correlation (Pearson's r) | High correlation (e.g., >0.90) with predicate device | 0.96 (95% CI: 0.94 to 0.97) | N/A (this is the comparator) |
| Slope (Passing Bablok) | Should be close to 1 (indicating proportional agreement) | 1.23 (95% CI: 1.2 to 1.28) | N/A |
| Intercept (Passing Bablok) | Should be close to 0 (indicating constant agreement) | -1.19 (95% CI: -1.43 to -0.81) | N/A |
| Range of Values (Urine) | Comparable to clinical needs and predicate device | 0.4 to 66.7 µg/24 Hr | 0.8 to 80.2 µg/24 Hr |
| Analytical Performance | |||
| Analytical Sensitivity | Sufficient for clinical measurement (comparable or better than predicate) | 1.2 ng aldosterone/dL | 0.7 ng aldosterone/dL |
| Within-run (%CV) | Low variability (e.g., |
§ 862.1045 Aldosterone test system.
(a)
Identification. An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.(b)
Classification. Class II.