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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 Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay (or simply: Nichols Advantage® H-hCG Assay) is intended for use with the Nichols Advantage® Specialty System for the quantitative measurement of hyperglycosylated human chorionic gonadotropin (H-hCG), a placental hormone in human serum, or for the qualitative determination of H-hCG in urine as an aid in the detection of pregnancy. These diagnoses should be made with appropriate additional clinical evidence. Clinical considerations and professional judgment should be applied to any test device result as with this Nichols H-hCG chemiluminescent immunoassay.

The Nichols Advantage® H-hCG Assay is used in conjunction with two H-hCG calibrators which are used to calibrate the assay and are provided separately to the reagent cartridge. The control is used for the monitoring of the accuracy and precision of the Nichols Advantage H-hCG Assay and successful calibration is confirmed using three H-hCG controls also provided separately to the calibrators and reagent cartridge.

The Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin Assay (i.e., Nichols Advantage® H-hCG Assay) is a two-step, two-site immunochemiluminometric assay for use with the Nichols Advantage® Specialty System, for the measurement of H-hCG as an aid in the detection of pregnancy. This new Nichols Advantage® H-hCG Assay Jas with the predicate of the Diagnostic Products Corporation (= DPC) termed: the DPC IMMULITE® hCG Immunoassay (K990222; cleared 2/26/99)] is a two-step, two-site immunochemiluminometric assay for use with the Nichols Advantage® Specialty System.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for Nichols Advantage® H-hCG Assay

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample sizes used for the test set and the data provenance

• Precision/Reproducibility: Patient or patient pool samples were evaluated. An "accelerated format of the NCCLS EP-5 protocol" was used, involving two replicates of each specimen run on each of four assays per day over a 10-day period, yielding 80 data points.
• Linearity/Assay Reportable Range:
  • n = 61 "apparently pregnant and health female subjects" reporting 0-2 weeks of gestation.
• Detection Limit/Assay Cut-off (Non-pregnant subjects): n = 81 "non-pregnant apparently health female subjects."
• Method Comparison (Serum): n = 659 total samples (479 pregnant, 180 non-pregnant).
• Method Comparison (Urine): n = 777 total samples (632 pregnant, 145 non-pregnant).
• Expected Values/Reference Range (Cut-off establishment):
  • n = 178 serum samples (apparently healthy and non-pregnant adult women, age 17-64).
  • n = 85 random urine samples (apparently healthy and non-pregnant adult women, age 17-71).
  • Both groups were "ambulatory, free-living, southern California community-dwelling."
• Expected Values (Pregnant women): n = 357 first trimester serum samples from "apparently healthy pregnant women" (categorized by gestational weeks/LMP).
• Data Provenance: The document explicitly states that samples for establishing expected values/reference ranges were from "southern California community-dwelling adult women." For other studies, data provenance is not explicitly stated but is implied to be clinical samples from similar populations as tested by the predicate device. The samples for determining cross-reactivity of various hCG forms were provided by Columbia University or Sigma Chemical Co. All clinical data presented appears to be retrospective, derived from collected clinical samples.

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

The document does not explicitly state that experts were used to establish the ground truth for the test set. Instead, the ground truth for pregnancy status (pregnant vs. non-pregnant) relies on:

• Clinical reporting: "apparently pregnant and health female subjects [i.e., those reporting 0 to 2 weeks of gestation]" and "apparently healthy pregnant women."
• Comparison to a predicate device: The DPC IMMULITE® hCG Immunoassay (K990222) is used as the reference standard for method comparison, implying its results are the accepted ground truth for hCG levels and pregnancy status.
• Lack of specific mention: There is no mention of radiologists, pathologists, or other clinical experts adjudicating cases for ground truth.

4. Adjudication method (for the test set)

There is no explicit mention of an adjudication method (like 2+1, 3+1, none) for establishing ground truth from multiple experts. The ground truth appears to be based on:

• Self-reported gestational status.
• Comparison with a well-established predicate device, implying its results serve as a form of reference standard.

5. 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 MRMC comparative effectiveness study was done or mentioned. This device is an immunoassay (laboratory test system), not an AI-assisted diagnostic imaging or clinical decision support system that would involve human "readers" or AI assistance. The comparison is between two laboratory assay methods.

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

Yes, the device operates as a standalone algorithm/system without human-in-the-loop performance influencing the assay results. The Nichols Advantage® H-hCG Assay itself is a laboratory instrument that quantitatively measures H-hCG. Interpretation of results (e.g., positive for pregnancy) is based on defined cut-off values (e.g., >= 1.0 ng/mL), which are determined by the assay and not subject to real-time human interpretation for each primary result. Clinical considerations and professional judgment are applied after the objective result is obtained, suggesting the assay itself is standalone.

7. The type of ground truth used

The primary ground truth used is a combination of:

• Clinical status (self-reported/historical): "apparently pregnant" or "non-pregnant" status of individuals.
• Predicate device results: The DPC IMMULITE® hCG Immunoassay results serve as a comparative ground truth/reference standard for establishing correlation and agreement. For linearity, the DPC values were used to correlate with the NID values.
• Derived cut-off values: For the "detection limit" studies, the ground truth was derived from statistical analysis of H-hCG levels in known non-pregnant individuals.

8. The sample size for the training set

The document does not explicitly differentiate between "training" and "test" sets in the context of machine learning. For an immunoassay, the concept of a training set is typically represented by the samples and data used to develop the assay, establish its calibration, and set initial performance parameters. The document focuses on the validation or performance characteristic studies. For the purposes of this request, if we consider "training" analogous to the data used to define the assay's operational parameters and reference ranges, then:

• For establishing reference ranges/expected values: n=178 serum samples (non-pregnant) and n=85 urine samples (non-pregnant) were used to determine the decision threshold. n=357 first trimester serum samples (pregnant) were used to establish expected values by gestational week.

9. How the ground truth for the training set was established

For the data used to establish assay parameters and reference ranges:

• The ground truth (pregnant or non-pregnant status) was established based on the clinical status of the subjects (e.g., "apparently healthy and non-pregnant adult women," "pregnant women"). This likely involves a combination of medical history, last menstrual period, and potentially other clinical assessments not detailed in the summary.
• Analytical measures: The "ground truth" for linearity and method comparison was provided by the predicate device's quantitative results, allowing for a direct comparison and correlation study. The predicate device's established performance served as the benchmark.

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The Nichols Advantage® Cortisol assay is intended for use with the Nichols Advantage® Specialty System for the quantitative determination of cortisol concentrations in human serum, EDTA plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

The Nichols Advantage Cortisol Assay Calibrators are intended for adjustment of the stored curve for the Nichols Advantage Cortisol assay.

The Nichols Advantage Cortisol assay contains sufficient reagents for 100 tests. The assay is a chemiluminescent competitive binding assay for cortisol in human serum, plasma, and urine.

Here's a breakdown of the acceptance criteria and study information for the Nichols Advantage® Cortisol assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a formal, quantifiable manner for the overall device's performance. Instead, it compares the performance characteristics of the new device (Nichols Advantage Cortisol) to a predicate device (DPC Coat-A-Count Cortisol RIA). The implicit acceptance criterion appears to be "substantial equivalence" to the predicate device across various performance metrics.

Note: The conclusion states: "These data... demonstrate safety and effectiveness of the Nichols Advantage Cortisol for its intended in vitro diagnostic use. Furthermore, based on performance characteristics, the Nichols Advantage Cortisol assay is substantially equivalent to the predicate method." This implies the reported performance values fell within acceptable limits relative to the predicate device for FDA clearance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 150 serum samples
• Data Provenance: The document states the samples were "human serum samples in which the clinical diagnosis were unknown." It does not specify the country of origin. Given the manufacturer's address in San Clemente, CA, United States, it's reasonable to infer a U.S. origin, though not explicitly stated. The study appears to be retrospective as it uses existing "serum samples."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the test set. The comparison is made against a legally marketed predicate device, where the predicate device's results serve as the reference for comparison.

4. Adjudication Method for the Test Set

Not applicable. There was no mention of an adjudication process as the comparison was against a predicate device's quantitative measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of an in vitro diagnostic assay, comparing it to an existing assay, rather than assessing human reader performance.

6. If a Standalone Study Was Done

Yes, a standalone study was performed to characterize the performance of the Nichols Advantage Cortisol assay on its own (e.g., within-run precision, total precision, recovery, linearity, analytical sensitivity). The results of these intrinsic performance metrics are reported in the "Comparison of Performance Characteristics" table.

7. The Type of Ground Truth Used

The "ground truth" for the comparative study was the results obtained from the predicate device, DPC Coat-A-Count Cortisol RIA. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic assays.

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" or its size. In the context of IVD assays like this, the "development" or "training" might involve internal validation and optimization, but specific training set sizes are not typically reported in 510(k) summaries for device performance. The reported study of 150 samples appears to be the primary validation data.

9. How the Ground Truth for the Training Set Was Established

As no specific training set is mentioned, the method for establishing its ground truth is also not described. If there was an internal development phase, the ground truth for any optimization would likely be established in a similar manner to the reported comparison study (i.e., comparison to established methods or reference standards).

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The Nichols Advantage® Chemiluminescence Intact Parathyroid Hormone Immunoassay is intended for use with the Nichols Advantage Specialty System for the quantitative determination of intact parathyroid hormone in serum, EDTA plasma, and heparinized plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism. Measurements of intact parathyroid hormone levels are also used as an aid in monitoring therapeutic intervention of secondary hyperparathyroidism that frequently occurs in chronic kidney disease. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

The Nichols Advantage Intact PTH assay contains sufficient reagents for 100 tests. The assay is a two-site chemiluminometric assay specific for Intact PTH.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Nichols Advantage® Chemiluminescence Intact Parathyroid Hormone device:

Based on the provided 510(k) summary, the device is an immunoassay for quantitative determination of intact parathyroid hormone (PTH). The primary purpose of this type of submission (510(k)) is to demonstrate substantial equivalence to a predicate device, rather than to establish a new clinical utility or performance against fixed acceptance criteria in a novel clinical study.

The "acceptance criteria" in this context are not defined as specific performance thresholds (e.g., sensitivity, specificity, accuracy) against a clinical gold standard, but rather relate to the demonstration that the modified device performs similarly to or better than the predicate device, and that the modifications do not introduce new safety or effectiveness concerns.

The summary states: "The device with modified labeling is substantially equivalent to the predicate device."

Here's a breakdown of the information requested, based on the provided document:

1. A table of acceptance criteria and the reported device performance

Given the nature of a 510(k) for an immunoassay where the core technology is unchanged and the focus is on demonstrating equivalence after minor modifications, the "acceptance criteria" are implied comparisons to the predicate device's established performance or confirmation of expected analytical characteristics.

• Crossreactivity to human PTHrP 1-40 was determined to not cross react in the assay. (This indicates good specificity against PTHrP). |
  | No Change in Technology: The core assay methodology should remain consistent with the predicate device. | - There is no change in technology from the original device cleared under K962598. |

2. Sample size used for the test set and the data provenance

The document does not provide specific sample sizes
for the studies conducted. It only generally describes the types of comparisons made (e.g., 6 different blood collection tubes).

Data provenance (e.g., country of origin, retrospective/prospective) is also not specified in the provided text.

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

This type of information is generally not applicable to an immunoassay 510(k) submission focused on analytical performance and substantial equivalence. Ground truth for an immunoassay is typically established via reference methods or clinical samples with confirmed conditions, not expert consensus on image interpretation. The document does not mention any expert review or qualification for establishing "ground truth."

4. Adjudication method for the test set

Not applicable, as there's no mention of expert review or adjudication.

5. 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

This is not applicable to an immunoassay for quantitative measurement of a biomarker. MRMC studies are relevant for imaging devices or AI tools that assist human readers in interpretation.

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

This is not applicable. The device is an immunoassay, which is a standalone diagnostic test performed in a lab, generating a numerical result. It doesn't involve an "algorithm only" component in the sense an AI diagnostic tool would, nor does it typically involve a "human-in-the-loop" for interpreting its direct output in the same way an imaging AI would. The human (clinician) interprets the results of the test in conjunction with other clinical data.

7. The type of ground truth used

For an immunoassay, "ground truth" for demonstrating analytical performance typically involves:

• Reference standards/calibrators: For accuracy, linearity, and precision.
• Spiked samples: To assess recovery and interference.
• Clinical samples with established diagnoses: To assess clinical performance (though this document focuses on analytical equivalence, not a new clinical claim).

The document details analytical comparisons, but does not explicitly state the "ground truth" methodology for specific analytical parameters. For cross-reactivity, it appears to use purified substances (human PTH 7-84, human PTHrP 1-40). For blood tube comparisons and specimen stability, the ground truth would be the results obtained from a reference or established method/tube, against which others are compared.

8. The sample size for the training set

This is not applicable to an immunoassay device, which is not an AI/machine learning algorithm requiring a "training set."

9. How the ground truth for the training set was established

This is not applicable for the same reason as #8.

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The Nichols Advantage® Bio-Intact PTH (1-84) Immunoassay is intended for use with the Nichols Advantage® Specialty System to measure the levels of parathyroid hormone in serum, EDTA plasma and heparinized plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism. Measurements of parathyroid hormone levels with the Bio-Intact PTH (1-84) Immunoassay are also used as an aid in monitoring therapeutic intervention of secondary hyperparathyroidism that frequently occurs in chronic kidney disease. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

The Bio-Intact PTH (1-84) Assay is a two-site chemiluminescence assay for use with the Nichols Advantage® Specialty System.

Here's a summary of the acceptance criteria and study information for the Nichols Advantage® Bio-Intact PTH (1-84) Immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission describes the device as a modification of a predicate device (K013992). The acceptance criteria are implicit in the comparison to the predicate device and the reported performance characteristics.

2. Sample Size Used for the Test Set and Data Provenance

• Method Comparison 1 (Serum Analysis):
  • Sample Size: 305
  • Data Provenance: Not explicitly stated, but clinical samples are implied for method comparison. The text does not specify country of origin or if prospective/retrospective.
• Method Comparison 2 (Renal Dialysis Samples):
  • Sample Size: 3187
  • Data Provenance: Not explicitly stated. Clinical samples from renal dialysis patients are implied. The text does not specify country of origin or if prospective/retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is an in vitro diagnostic (IVD) immunoassay. The concept of "experts" establishing ground truth as in imaging or clinical diagnosis is not directly applicable. The ground truth for method comparison studies in IVDs is typically established by the predicate device or a reference method. In this case, the Nichols Advantage Intact PTH Assay (the predicate device, K013992) served as the comparator for method comparison studies.

4. Adjudication Method for the Test Set

Not applicable for this type of IVD immunoassay study. The comparison is quantitative against a predicate device.

5. 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

Not applicable. This is an immunoassay, not an imaging or interpretive device that involves human "readers" or "AI assistance."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This device is a standalone algorithm/device. Its performance is measured directly by its ability to quantify PTH levels in biological samples. It operates without human interpretive input in the measurement process itself, although clinical interpretation of results requires a human. The performance metrics (precision, method comparison) are standalone device metrics.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence and performance characteristics was established by:

• Quantitative values obtained from the predicate device: The Nichols Advantage Intact PTH Assay was used as the comparator for the method comparison studies.
• Established analytical methods: Precision, sensitivity, linearity, etc., are measured against established performance specifications for immunoassays.

8. The Sample Size for the Training Set

The provided text only details the performance studies for the modified device. It does not contain information about a separate "training set" for an algorithm in the way machine learning models would have one. For an immunoassay, method development and optimization would involve numerous samples, but these are not typically reported as a "training set" in a 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

As above, the concept of a "training set" with established ground truth as in machine learning does not directly apply to this immunoassay submission. Assay development and validation would rely on known control materials, spiked samples, and comparison to established reference methods or predicate devices during the R&D phase to optimize assay parameters.

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The Nichols Advantage® Bio-Intact PTH (1-84) immunometric assay is intended for use with the Nichols Advantage® Specialty System to measure the levels of parathyroid hormone in serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

The Nichols Advantage® Bio-Intact PTH (1-84) assay is a fluorescence immunometric assay for quantifying PTH in human serum or plasma.

The provided text describes a Special 510(k) submission for the "Nichols Advantage Bio-Intact PTH (1-84)" immunoassay. This submission focuses on
labeling changes and new clinical performance data rather than establishing new acceptance criteria or presenting a comprehensive study of the device meeting pre-defined acceptance criteria.

The submission outlines changes to the "Expected Values section" in the labeling and includes a reference range study. It also details a new clinical performance study. However, it does not explicitly state acceptance criteria in numerical or qualitative terms, nor does it present a formal study demonstrating the device meets such criteria with specific performance metrics against those criteria.

Therefore, the requested information elements related to specific acceptance criteria and a study proving the device meets them cannot be directly extracted from the provided text in the typical format you might expect for a pre-market submission focused on efficacy.

However, I can provide the available information from the text, interpreting the clinical performance study as the closest equivalent to a study demonstrating device performance.

Here's the breakdown of what can be extracted, and where information is not available:

Acceptance Criteria and Device Performance

Since specific acceptance criteria are not explicitly stated in the provided text, I will interpret the outcomes of the clinical performance study as the "reported device performance." The purpose of this study was to provide clinicians and laboratories with new information to interpret PTH results, particularly for establishing a local reference range.

Study Details (Clinical Performance Study)

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

   • Test Set Sample Size: n=63 patients with surgically confirmed primary hyperparathyroidism, n=6 patients with hypoparathyroidism, n=3 patients with hypercalcemia due to malignancy, and n=276 normal individuals.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The text refers to it as a "Study was performed," suggesting it could be prospective, but this is not explicitly stated.

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

   • This information is not provided in the text. The ground truth for the patient groups (e.g., "surgically confirmed primary hyperparathyroidism") is implied to be clinical diagnosis, but the involvement of specific experts in establishing this for the test set is not detailed.

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

   • This information is not provided in the text.

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:

   • This device is an in vitro diagnostic immunoassay (a laboratory test for measuring PTH levels), not an AI/imaging device that would typically involve human "readers" or an MRMC study comparing human performance with and without AI assistance. Therefore, this type of study was not applicable and not performed.

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

   • This device is an in vitro diagnostic immunoassay. Its "performance" is inherently standalone in the sense that the assay itself measures the analyte. Human involvement comes in collecting samples, running the assay, and interpreting the raw result in a clinical context. The clinical performance study described assesses the device's ability to differentiate patient populations based on its PTH measurements, which is effectively its standalone performance in that context.

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

   • The ground truth for the patient cohorts appears to be clinical diagnosis, with some explicitly stated as "surgically confirmed." For "normal individuals," the ground truth would be the absence of relevant disease or symptoms.

7. The sample size for the training set:

   • This submission describes a clinical performance study on specific patient cohorts intended to provide data for interpretation, particularly for developing local reference ranges. It does not mention a "training set" in the context of machine learning model development. The data appears to be for characterizing performance across specific clinical conditions, not for training a predictive algorithm.

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

   • As there is no mention of a "training set" in this context, this information is not applicable.

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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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The Nichols Advantage® Chemiluminescence Helicobacter pylori IgG Antibodies Immunoassay is intended for use with the Nichols Advantage® Specialty System for the qualitative determination of anti-H. pylori IgG in human serum to aid in the diagnosis of infection by H. pylori.

The Nichols Advantage® Helicobacter pylori IgG Antibodies Assay is a two-site chemiluminescence assay for use with the Nichols Advantage® Specialty System. Nichols Institute Diagnostics utilizes chemiluminescence acridinium esters as the label in its specialty chemiluminescence system. Acridinium esters emit light upon treatment with hydrogen peroxide and an alkaline solution. The Trigger 1 solution contains hydrogen peroxide in diluted acid and Trigger 2 solution contains diluted sodium hydroxide. The system automatically injects Trigger solutions 1 and 2 into the wells of the cuvette which oxidize the acridinium ester. The oxidized product is in an excited state. The subsequent return to ground state results in the emission of light, which is quantified in two seconds and is expressed in relative light units (RLU) by the integrated system luminometer. The Nichols Advantage® Anti-H. pylori IgG Assay is a two-site chemiluminescence immunoassay for the measurement of anti-H. pylori IgG in human serum. It utilizes an acridinium-ester-labeled mouse monoclonal anti-human IgG antibody and a biotinylated H. pylori antigen cocktail. The sample containing anti-H. pylori IgG antibodies is incubated with the biotinylated antigen cocktail and magnetic particles for 10 minutes at 37°C. Free, unbound biotinylated antigens and anti-H. pylori IgG antibodies are separated from the complex bound to the magnetic particles by aspiration of the reaction mixture and subsequent washing. Thereafter, acridinium-labeled anti-human IgG antibodies are added to the reaction mixture and a second 10 minute incubation follows creating the sandwich complex. Free, unbound acridinium-labeled anti-human IgG antibodies are separated from the complex bound to the magnetic particles by aspiration of the reaction mixture and subsequent washing. The wells containing the washed magnetic particles are transported into the system luminometer, which automatically injects Trigger 1 and Trigger 2, initiating the chemiluminescence reaction. The light is quantitated by the luminometer and expressed as RLU. The amount of bound-labeled antibody is directly proportional to the titer of anti-H. pylori IgG antibodies in the sample. The Nichols Advantage Specialty System automatically handles sample dilution as well as sample and reagent additions, the temperature-controlled incubation, separation/washing step, and measurement of the light output. It calculates test results for controls and patient samples from the stored calibration curve, and generates a printed report, which includes patient information.

Here's an analysis of the provided text, extracting the requested information about acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance for Nichols Advantage® H. pylori IgG Antibodies Immunoassay

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it presents performance characteristics and compares them to the predicate device, implying that the Nichols Advantage® assay's performance is considered acceptable if its characteristics are comparable or superior and meet the intended use.

Based on the "Performance Characteristics" section, here are the reported performance details:

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the "Method Comparison" test set, nor does it specify the country of origin of the data or whether the study was retrospective or prospective. It only presents the "Range of Results" for the method comparison as "1:13 to 1:5526" for the Nichols Advantage® assay and "1:97 to 1:9504" for the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not describe the use of experts to establish ground truth for the method comparison. The comparison is between the Nichols Advantage® assay and a predicate device (Orion Diagnostica Pyloriset® EIA-G Immunoassay), suggesting the predicate device's results served as a reference.

4. Adjudication Method for the Test Set

No adjudication method is described, as the comparison is primarily assay-to-assay.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or mentioned in the document. This is an in vitro diagnostic device, and MRMC studies are typically for imaging or interpretation tasks where human readers are involved.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

The device itself is an automated immunoassay system. The performance characteristics described for the Nichols Advantage® system are inherently standalone (algorithm/device only) without human-in-the-loop performance influencing the assay's raw output. The system automatically handles processes and calculates results.

7. Type of Ground Truth Used

The ground truth for the method comparison study appears to be the results obtained from the predicate device, the Orion Diagnostica Pyloriset® EIA-G Immunoassay. The document states a "Method Comparison" was performed, and then provides "Concordance," "Percent Agreement Positive," and "Percent Agreement Negative" between the new device and the predicate. This implies the predicate's results were used as a reference for comparison.

8. Sample Size for the Training Set

The document describes an immunoassay, not a machine learning algorithm that typically has a "training set." Therefore, a "training set" in the context of data used to train an algorithm is not applicable here. The assay relies on established chemical and immunological principles, with performance validated through analytical and clinical studies.

9. How the Ground Truth for the Training Set Was Established

As noted above, a "training set" for an algorithm is not applicable for this type of device. The assay's analytical performance (intra-assay, inter-assay, recovery, parallelism) would have been established using characterized samples with known concentrations/titer ranges, but this is part of analytical validation, not algorithm training.

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The Nichols Advantage QuiCk-IntraOperative™ Bio-Intact PTH (1-84) is intended for use with the Nichols Advantage® Specialty System to measure parathyroid hormone in EDTA plasma and human serum. This procedure is recommended for rapid intraoperative measurement of Intact PTH 1-84 using EDTA plasma or human serum. The reagent cartridge is designed for single use only.

The Nichols Advantage QuiCk-IntraOperative Bio-Intact PTH (1-84) assay contains sufficient reagents for 26 tests. The assay is a two-site chemiluminometric assay specific for hPTH 1-84.

Here's a summary of the acceptance criteria and the study that proves the Nichols Advantage QuiCk-IntraOperative™ Bio-Intact PTH (1-84) device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a set of pass/fail thresholds. Instead, it presents performance characteristics of the new device and compares them to a predicate device to demonstrate substantial equivalence. The implication is that performance comparable to the predicate device is considered acceptable.

Note: While the new device's functional and analytical sensitivity, and precision, are numerically different from the predicate, the conclusion states that the data demonstrates "safety and effectiveness" and "substantial equivalence." This implies that these differences were deemed acceptable within the context of the intended use, likely because the performance characteristics are still clinically appropriate for rapid intraoperative measurement.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: One hundred thirty (130) remnant serum samples.
• Data Provenance: The clinical diagnosis for these samples was "unknown," indicating they were likely de-identified samples from a clinical laboratory or biobank. The country of origin is not specified but is presumed to be the USA, given the manufacturer's location and the FDA submission. The study appears to be retrospective as it used "remnant serum samples."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The study primarily focuses on comparing the new device's measurements to those of the predicate device, which serves as the reference or "ground truth" for the comparison. There's no indication that external experts were used to establish ground truth for the 130 samples beyond what the predicate device provided.

4. Adjudication Method for the Test Set:

This information is not provided. The comparison involved running each sample "in duplicate by both methods." There's no mention of an adjudication process for discrepancies beyond duplicate measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This device is an immunoassay (laboratory test), not an imaging or diagnostic device that typically involves human "readers." The study evaluates the analytical performance of the assay itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This device is an in vitro diagnostic immunoassay, which by nature is a standalone (algorithm only/device only) test. Its performance is measured independently of human interpretation in the sense of a radiologist reading an image. The study assesses the device's ability to accurately measure PTH concentrations.

7. The Type of Ground Truth Used:

The "ground truth" for the comparative study was established by the predicate device, Nichols Advantage Bio-Intact PTH (1-84) assay. The study aims to show substantial equivalence to this already-cleared device. The clinical diagnosis of the samples was unknown, so it was not directly based on pathology or patient outcomes for this specific comparative study.

8. The Sample Size for the Training Set:

This information is not provided. The document describes a comparison study for regulatory submission of an already developed device. It does not detail the development or training of the assay itself.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided. As explained above, the document focuses on the validation for regulatory submission, not the initial development or "training" of the assay.

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The Nichols Advantage® Bio-Intact PTH (1-84) immunometric assay is intended for use with the Nichols Advantage® Specialty System to measure the levels of parathyroid hormone in serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

The Nichols Advantage® Chemiluminescence Bio-Intact PTH (1-84) Immunoassay is a two-site immuno-chemiluminometric IVD device with sufficient reagents for 100 tests, that are performed entirely on the Nichols Advantage® Specialty System (K961142; cleared February 18, 1997). Two goat polyclonal antibodies directed at epitopes on intact human PTH are used. One antibody ("capture reagent") is chemically labeled with biotin, while the second antibody ("detection reagent") is chemically labeled with acridinium ester for subsequent quantitative measurements. A sample of patient serum (preferred) or plasma is added to an assay cuvette, followed by addition of the two goat anti-PTH antibodies and the streptaviding outed magnetic particles. The reaction mixture is allowed to incubate for 30 minutes at 37°C. Because of the high affinity interaction between biotin-labeled antibody and streptavidin, the sandwich complex is captured onto the streptavidin-coated magnetic particles. The captured complex bound to the magnetic particle passes to the Nichols Specialty System for a wash to remove unbound components and/or patient substances. The washed captured complex bound to the magnetic particles within the cuvette wells are analyzed Nichols Specialty System's luminometer via the automatic injection of reagents that initiate the acridinium-based chemiluminescence quantitative reaction. The light is measured by the Nichols Specially System's luminometer and expressed as Relative Light Units (RLU). The amount of PTH bound-labeled antibody is directly proportional to the concentration of intact PTH in the serum or plasma sample.

The Nichols Advantage® Chemiluminescence Bio-Intact PTH (1-84) Immunoassay is intended for use with the Nichols Advantage® Specialty System to measure parathyroid hormone levels in serum and EDTA plasma. This is used for the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The device performance was compared to a previously FDA-cleared predicate device, the Nichols Intact PTH Immunoassay.

Here is a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 305 patient serum samples.
• Data Provenance: The document does not specify the country of origin. It can be inferred that the samples were collected retrospectively as they were "patient serum samples" assayed by both methods without modifications, suggesting existing samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided in the document. The "ground truth" for the test set was essentially the results from the predicate device.

4. Adjudication Method for the Test Set

• Not applicable in this context. The comparison was directly between the values generated by the new device and the predicate device, not against an adjudicated "ground truth" from human experts.

5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for an in vitro diagnostic immunoassay, not an AI-powered image analysis or diagnostic assist device that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, this was a standalone performance study. The Nichols Advantage® Chemiluminescence Bio-Intact PTH (1-84) Immunoassay operates automatically on the Nichols Advantage® Specialty System, and its performance was assessed directly against the predicate device. There is no "human-in-the-loop" component to the analytical performance of the assay itself, beyond routine laboratory procedures.

7. The Type of Ground Truth Used

• The "ground truth" for evaluating the new device's performance was the results obtained from an FDA-cleared predicate device, the Nichols Intact PTH Immunoassay. This is a common approach for establishing substantial equivalence for new IVD devices.

8. The Sample Size for the Training Set

• This information is not provided. The term "training set" is typically associated with machine learning or AI algorithms. For this immunoassay, performance characteristics (precision, LOD, recovery etc.) are established through internal validation studies, not a distinct "training set" in the AI sense.

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. The calibration of the immunoassay system would be established using calibrators with known PTH concentrations, which are themselves traceable to a primary reference standard (though this specific traceability is not detailed in the provided text).

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