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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:

Study Information:

The primary "study" described is a method comparison and performance characteristic evaluation against a legally marketed predicate device.

1. Sample sizes used for the test set and data provenance:

   • Method Comparison (Urine): n = 118 urine samples.
   • Expected Values (Urine): n = 80 healthy adults (41 females, 39 males, age: 18 to 78 years).
   • Reproducibility for Urine: 4 urine samples, assayed in duplicate, once per day over 20 days.
   • Parallelism for Urine: 5 urine samples, serially diluted and assayed in duplicate.
   • Recovery for Urine: 3 sets of high and low urine samples mixed in various ratios, assayed in duplicate.
   • Urine Extraction Efficiency: 3 spiked urine samples, tested in n=8 replicates per level.
   • Data Provenance: Not explicitly stated, but given the manufacturer (Nichols Institute Diagnostics) and context, it is highly likely that the data was collected retrospectively or prospectively as part of an internal validation study for the device, presumably in the US or a region with comparable regulatory standards. It is retrospective in the sense that existing urine samples might have been used, but the testing itself would have been a prospective application of both assays.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is an in vitro diagnostic immunoassay, not an AI/medical imaging device that requires radiologist or clinician interpretation for establishing ground truth for individual cases. The "ground truth" for the test set (the 118 urine samples) is the measurement obtained from the predicate device (DSL-8600 ACTIVE® Aldosterone Coated-Tube Radioimmunoassay Kit), which is itself a laboratory assay.
   • For the Expected Values study, "80 healthy, prescription expected forchoo fangedults (41 females and 39 males, age:18 to 78 years)" were used. The 'ground truth' here is their healthy status, presumably determined by routine medical screening, not by expert consensus on specific diagnostic cases.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This is not a study involving human readers or expert consensus on case interpretation that would require adjudication. The method comparison uses quantitative measurements from two different laboratory assays.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is an IVD device, not an AI algorithm for image interpretation or diagnosis that would involve human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, this is an intrinsic performance study of the standalone device (the Nichols Advantage® Aldosterone Assay). Its performance is evaluated objectively through analytical characteristics (precision, recovery, linearity, specificity) and compared to a predicate device. There is no human-in-the-loop component in the measurement process itself; a laboratory technician operates the system, but the device provides the quantitative result.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the method comparison study, the "ground truth" for the 118 urine samples was the measurement obtained from the predicate device (DSL-8600 ACTIVE® Aldosterone Coated-Tube Radioimmunoassay Kit).
   • For other analytical performance studies (precision, recovery, linearity, specificity, extraction efficiency), the "ground truth" is established through known concentrations of analytes (e.g., spiked samples, reference materials) or by the absence/presence of cross-reactants.
   • For establishing the Expected Values, the "ground truth" was the clinical health status (healthy individuals) of the sampled population.

7. The sample size for the training set:

   • Not applicable in the conventional sense of machine learning. This is a traditional immunoassay, not an AI/ML algorithm that requires a "training set" to learn from data. The assay's performance is based on its chemical and immunological design.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" in the context of an immunoassay. The device is built based on established biochemical principles.

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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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