(14 days)
The Nichols Advantage® Aldosterone assay is intended for use with the Nichols Advantage® Specialty System to quantitatively measure aldosterone in human serum and EDTA plasma. Aldosterone measurements are used 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 contains sufficient reagents for 100 tests. The assay is a competitive binding assay for aldosterone in human serum or plasma.
The Nichols Advantage® Aldosterone assay is a competitive binding immunoassay intended for quantitative measurement of aldosterone in human serum and EDTA plasma using the Nichols Advantage Specialty System. Aldosterone measurements are used in the diagnosis and treatment of conditions such as primary aldosteronism, hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other electrolyte imbalances.
The device's performance was compared to a predicate device, the DPC Coat-A-Count Aldosterone RIA (K831178), to establish substantial equivalence.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense for all features. However, it provides comparative performance characteristics between the Nichols Advantage Aldosterone and the predicate device. The implied acceptance is that the Nichols Aldosterone performs comparably to the predicate.
| Feature | Predicate Device (DPC Aldosterone) | Nichols Advantage Aldosterone |
|---|---|---|
| Comparison Study (Quantitative) | ||
| Range (Method X - DPC) | 2.7 to 125 ng/dL | Not directly stated (Y=1.04X+0.1) |
| Range (Method Y - Nichols) | Not directly stated | 2.7 to 120 ng/dL |
| Regression (Passing Bablok) | Y = 1.04X + 0.1 | N/A |
| (95% CI Slope) | (0.98 to 1.10) | N/A |
| (95% CI Intercept) | (-1.0 to +1.1) | N/A |
| Regression (Deming) | Y = 1.09X - 0.6 | N/A |
| (95% CI Slope) | (1.03 to 1.15) | N/A |
| (95% CI Intercept) | (-3.2 to +2.1) | N/A |
| Pearson's Correlation (r) | N/A | 0.96 |
| Performance Characteristics | ||
| Within-Run Precision (%CV) | 2.3-5.4% | 2.9-14.0% |
| Total Precision (%CV) | 3.8-15.7% | 4.9-18.6% |
| Recovery | 86-111% | 88-110% |
| Linearity | 100-119% | 91-116% |
| Analytical Sensitivity | 1.1 ng/dL | 1.2 ng/dL |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: One hundred three (103) remnant serum samples.
- Data Provenance: The clinical diagnosis for these samples was unknown. The document does not specify the country of origin, but given the manufacturer's location (San Clemente, CA) and the FDA submission, it's highly likely to be U.S.-based. The samples were "remnant," suggesting a retrospective collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. This device is an in vitro diagnostic immunoassay measuring an analyte concentration. The "ground truth" for the test set was the measurement result obtained by the predicate device (DPC Coat-A-Count Aldosterone RIA), not expert consensus on an image or clinical observation.
4. Adjudication Method for the Test Set:
Not applicable. The study involved a direct comparison of quantitative measurements from two immunoassay methods on the same samples. There was no need for expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted as this is an in vitro diagnostic device for quantitative measurement, not an imaging device requiring human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the core of the submission is a standalone performance evaluation of the Nichols Advantage Aldosterone assay, comparing its quantitative results to a legally marketed predicate device without human-in-the-loop interaction for result interpretation beyond running the assay.
7. The Type of Ground Truth Used:
The ground truth for comparison was the quantitative measurement obtained from the predicate device (DPC Coat-A-Count Aldosterone RIA) on the same serum samples. This is a common approach for demonstrating substantial equivalence for new IVD devices by comparing them to an established, legally marketed assay.
8. The Sample Size for the Training Set:
Not applicable. This document describes the validation of an immunoassay kit, not a machine learning algorithm that requires a "training set" in the conventional sense. The development of the assay would have involved internal optimization and validation, but this specific submission focuses on the performance comparison to the predicate.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a "training set" in the context of an AI/ML algorithm.
§ 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.