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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:

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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.

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.

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