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Immunoassay for the in vitro quantitative determination of cortisol in human urine. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

The Elecsys Cortisol III immunoassay employs a competitive test principle using a cortisol-specific biotinylated monoclonal antibody and a cortisol-derivative labeled with a ruthenium complex. The Elecsys Cortisol III immunoassay is intended for the in vitro quantitative determination of cortisol in human urine. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland on the cobas e immunoassay analyzers.

Results are determined via a calibration curve which is instrument-specifically generated by a two-point calibration and a master curve provided via the cobas link.

The Elecsys Cortisol III immunoassay reagent Rack Pack comprises the following:

M Streptavidin-coated microparticles (transparent cap), 1 bottle, 12.4 mL:
Streptavidin-coated microparticles 0.72 mg/mL; preservative.

R1 Anti-cortisol-Ab~biotin (gray cap), 1 bottle, 21.0 mL:
Biotinylated monoclonal anti-cortisol antibody (mouse) 18 ng/mL; danazol 20 μg/mL; MES buffer 100 mmol/L, pH 6.0; preservative.

R2 Cortisol-peptide~Ru(bpy) (black cap), 1 bottle, 21.0 mL:
Cortisol derivative (synthetic), labeled with ruthenium complex, 5 ng/mL; danazol 20 μg/mL; MES buffer 100 mmol/L, pH 6.0; preservative.

MES = 2-morpholino-ethane sulfonic acid

The provided 510(k) summary for the Elecsys Cortisol III device focuses primarily on non-clinical performance evaluations to demonstrate substantial equivalence to a predicate device. It does not describe a study to prove performance against specific acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, or agreement with ground truth in a clinical context) with a test set of patient samples.

Here's an analysis of the available information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense for diagnostic performance metrics like sensitivity, specificity, or agreement against a clinical ground truth. Instead, it details performance specifications for various analytical aspects and states that these "met the predefined acceptance criteria." These are primarily related to the analytical performance of the assay itself.

2. Sample Size and Data Provenance for Test Set

• Precision (Repeatability & Intermediate Precision): Human urine samples (24-hour urine) and controls. Two replicates per run, two runs per day for 21 days for each of 4 human urine samples and 2 controls. (Total of $4 \text{ samples} \times 2 \text{ replicates/run} \times 2 \text{ runs/day} \times 21 \text{ days} = 336$ measurements for human urine, plus $2 \text{ controls} \times 2 \text{ replicates/run} \times 2 \text{ runs/day} \times 21 \text{ days} = 168$ measurements for controls. Or potentially 42 total runs for each sample/control).
• Analytical Sensitivity (LoB, LoD, LoQ): Not specified beyond "reagents and calibrators" likely being used.
• Linearity/Assay Reportable Range: Dilution series contained a minimum of 9 concentrations. Number of samples not explicitly stated but implies a set of samples specifically created to span the measuring range.
• HAMA: Not specified.
• Endogenous Interferences: Human urine samples (24-hour urine) were used. The number of samples is not explicitly stated.
• Analytical Specificity/Cross-Reactivity: Human urine (24-hour urine) samples. Specific numbers not provided beyond "samples were measured in the presence and absence of the potential cross-reactants."
• Exogenous Interferences – Drugs: In vitro tests performed on 12 commonly used pharmaceuticals and additional special drugs. This implies spiked samples rather than a "test set" of patient samples.
• Method Comparison: "Native 24 h urine samples" for comparison with the predicate device. The number of samples is not specified.
• Reference Range Study: Samples collected from an "apparently healthy population in the United States" across three study sites. The exact number of samples is not provided, but it's sufficient for establishing 2.5th and 97.5th percentiles (typically requires 120+ samples according to CLSI EP28-A3c).

Data Provenance: The document explicitly states "human urine samples (24-hour urine)" for most studies and for the reference range, "collected across three study sites... in the United States." This indicates prospective collection for the reference range study specifically for generating normal values applicable to the US population. For other analytical performance claims, the sample type (human urine) is generally mentioned, suggesting a similar provenance, likely for prospective testing within the manufacturer's lab or clinical sites.

3. Number of Experts and Qualifications for Ground Truth

Not applicable for the Elecsys Cortisol III. This is an in vitro diagnostic device (IVD) that quantitatively measures a biomarker (cortisol). The "ground truth" for such devices is typically established through recognized analytical standards, reference methods, and comparison to a legally marketed predicate device, rather than expert consensus on diagnostic images or clinical assessments. The closest to "ground truth" in this context would be the accuracy against a gold standard analytical method or purified cortisol standards. These details are not provided but are implicit in the validation that relies on CLSI guidelines.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative IVD for a biomarker, diagnostic classification and adjudication by experts are not relevant to the described analytical studies. The performance is assessed by comparison to expected analytical results or a predicate device.

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

Not applicable. MRMC studies are typically for imaging devices or software that assist human readers in making a diagnosis. The Elecsys Cortisol III is an automated in vitro diagnostic immunoassay for quantitative measurement of cortisol in urine. It does not involve human readers interpreting cases with or without AI assistance.

6. Standalone Performance Study

Yes, the entire submission describes standalone performance. The Elecsys Cortisol III is an immunoassay designed to operate on cobas e immunoassay analyzers. All the performance data (precision, sensitivity, linearity, interference, cross-reactivity, method comparison) are generated directly from the device's measurement of cortisol in urine samples. The device itself performs the quantitative determination without human-in-the-loop interpretation impacting the measurement results. The method comparison study directly compares its quantitative output to the predicate device's quantitative output.

7. Type of Ground Truth Used

For an IVD like Elecsys Cortisol III, the "ground truth" for the test set is established by:

• Reference standards/Calibrators: For analytical sensitivity (LoB, LoD, LoQ) and linearity studies, known concentrations of cortisol (or materials traceable to them) are used.
• Predicate device comparison: For method comparison, the results from the Elecsys Cortisol III are compared to those obtained from the legally marketed ARCHITECT Cortisol (K062204), which serves as the established "truth" or benchmark for demonstrating substantial equivalence.
• Spiked samples/characterized samples: For interference and cross-reactivity studies, samples with known concentrations of interferents or cross-reactants are used to determine the device's accuracy in their presence.
• Clinically characterized healthy population samples: For the reference range study, samples from healthy individuals are used to establish normal ranges, though this isn't a "ground truth" for diagnostic accuracy.

8. Sample Size for the Training Set

The document does not mention "training set" in the context of an AI/ML algorithm. This device is an immunoassay, which relies on chemical reactions and optical detection, not an AI/ML model that requires a training set. The term "training set" is therefore not applicable here.

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

Not applicable. As noted above, there is no AI/ML training set for this immunoassay device.

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For in vitro diagnostic use in the quantitative determination of cortisol in serum, plasma (EDTA and lithium heparin), and urine using the ADVIA Centaur® XP system.

Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

The ADVIA Centaur Cortisol (COR) assay is a competitive immunoassay using direct chemiluminescent technology. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve with the reagent bar code. The ADVIA Centaur Cortisol (COR) assay is intended for use on the ADVIA Centaur family of analyzers. The ADVIA Centaur Calibrator E is a set of 2 level calibrators for the assay. Siemens recommends the use of commercially available quality control materials with at least two levels (low and high).

This document is focused on the ADVIA Centaur Cortisol (COR) assay, specifically the addition of plasma (EDTA and lithium heparin) as a sample claim. It seeks to demonstrate substantial equivalence to an existing device (K142723) which already had claims for serum and urine.

Acceptance Criteria and Reported Device Performance

The core of the study is to prove that the performance of the assay with the new plasma sample types is equivalent to its performance with serum (the established sample type). The primary acceptance criteria for this type of submission involve showing a strong correlation and minimal bias between the new sample type and the established one.

Table of Acceptance Criteria and Reported Device Performance:

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Immunoassay for the in vitro quantitative determination of cortisol in human serum, and plasma. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

Cortisol II CalSet is used for calibrating the quantitative Elecsys Cortisol II assay on the Elecsys and cobas e immunoassay analyzers.

The Elecsys Cortisol II assay makes use of a competition test principle using a monoclonal antibody which is specifically directed against cortisol. Endogenous cortisol which has been liberated from binding proteins with danazol competes with exogenous cortisol derivative in the test which has been labeled with ruthenium complex for the binding sites on the biotinylated antibody.

Results are determined via a calibration curve which is instrument specifically generated by 2point calibration and a master curve provided via reagent barcode.

The reagent working solutions include:

• rackpack (kit placed on instrument) .
  • Streptavidin coated microparticles, ş
  • Reagent 1 (Anti-cortisol-Ab~biotin) and ş
  • Reagent 2 (Cortisol-peptide~Ru(bpy)2+3). ş

The Cortisol II CalSet is a lyophilized human serum with added cortisol in two concentration ranges.

The CalSet includes:

• Cal 1 (approximately 12.5 nmol/L cortisol in a human serum matrix) .
• Cal 2 (approximately 1000 nmol/L cortisol in a human serum matrix) .

The provided document describes the Elecsys Cortisol II immunoassay and its associated calibrator, Cortisol II CalSet. It details various non-clinical performance evaluations and one clinical performance evaluation.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

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

The document does not explicitly state acceptance criteria in a dedicated table for each technical performance study. Instead, it presents the results of these studies and implies that these results demonstrate the device's performance is acceptable and supports substantial equivalence to the predicate device. For analytical specificity and method comparison, the document includes tables comparing some key characteristics with the predicate device. For other studies like precision, linearity, and sensitivity, it reports the performance without directly listing a pre-defined acceptance criterion.

However, I can extract the reported performance directly from the document for key metrics.

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The ADVIA Centaur® Cortisol (COR) Assay is for in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur XP system. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

The ADVIA Centaur Cortisol assay is a competitive immunoassay using direct chemiluminescent technology. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve with the reagent bar code. The ADVIA Centaur Cortisol Assay is intended for use on the ADVIA Centaur Family of analyzers. The ADVIA Centaur Calibrator E is a set of 2 level calibrators for the assay. Siemens recommends the use of commercially available quality control materials with at least two levels (low and high).

Here's a breakdown of the acceptance criteria and the study details for the ADVIA Centaur® Cortisol (COR) Assay, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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ARCHITECT® Cortisol is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cortisol in human serum, plasma or urine on the ARCHITECT i System. The ARCHITECT Cortisol assay is intended for use as an aid in the diagnosis and treatment of adrenal disorders.

The ARCHITECT Cortisol Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of cortisol in human serum, plasma or urine.

The ARCHITECT Cortisol assay is a delayed one-step immunoassay for the quantitative determination of cortisol in human serum, plasma or urine using CMIA technology with flexible assay protocols, referred to as Chemiflex®.

Here's a breakdown of the acceptance criteria and study details for the ARCHITECT Cortisol assay:

1. Table of Acceptance Criteria and Reported Device Performance:

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The AxSYM® Cortisol assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of Cortisol in human serum, plasma or urine on the AxSYM® System to aid in the diagnosis and treatment of adrenal disorders.

The AxSYM Cortisol assay utilizes Fluorescence Polarization Immunoassay (FPIA) technology. The AxSYM Cortisol Reagents and sample are pipetted in the following sequence:

• Sample and all AxSYM Cortisol Reagents required for one test are pipetted by the sampling probe into various positions of a Reaction Vessel (RV).
• Sample, the Cortisol Antiserum (antibody), pretreatment solution and Solution 4 (Line Diluent) are pipetted into one well of the RV.
• Additional pretreatment solution 4 (Line Diluent) are pipetted to the cuvette of the RV.
• The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.
  In the processing center, an aliquot of the predilution mixture and Solution 4 (Line Diluent) are transferred to the cuvette of the RV and the blank intensity of the sample is measured. A second aliquot of the predilution mixture is transferred to the cuvette along with the Cortisol Fluorescein Tracer. Cortisol from the sample and the Cortisol Fluorescein Tracer compete for binding sites on the antibody molecule. The intensity of polarized fluorescent light is measured by the FPIA optical assembly.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

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

   • Reproducibility (Precision) Study: Three buffer-based panel members (1, 2, and 3) were assayed, in replicates of two, at two separate times per day, for 20 days. This means each panel member had 80 measurements (2 replicates * 2 times/day * 20 days).
   • Comparison Study:
     • 130 endogenous and cortisol-spiked serum and sodium heparin plasma specimens.
     • 150 endogenous and cortisol-spiked urine specimens.
   • Expected Values Study:
     • 50 serum specimens (AM and PM collections).
     • 49 urine specimens (24-hour collection).
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective, as samples were "tested using the AxSYM Cortisol assay" and "collected from apparently healthy individuals" for the expected values study.

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

   • Not applicable as this is an in-vitro diagnostic (IVD) device measuring a biomarker, not interpreting imaging or clinical data that would require expert consensus. The "ground truth" for the comparison study is the result obtained from the predicate device (Beckman Access® Cortisol assay).

3. Adjudication method for the test set:

   • Not applicable. The "ground truth" for the comparison study is the result from the predicate device.

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:

   • Not applicable. This is an IVD device, not an AI-based imaging or
     diagnostic device that involves human readers interpreting results.

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

   • Yes, the performance characteristics (reproducibility and comparison studies) reflect the standalone performance of the AxSYM® Cortisol assay without human-in-the-loop performance. The "human-in-the-loop" for this type of device would involve laboratory technicians performing the test, but the performance metrics provided are for the assay itself.

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

   • For the comparison study, the ground truth was the results obtained from the predicate device (Beckman Access® Cortisol assay).
   • For the reproducibility study, the "ground truth" is inherent to statistical precision analysis from repeated measurements.
   • For the expected values study, the "ground truth" was the cortisol levels measured by the device itself in apparently healthy individuals to establish reference ranges.

7. The sample size for the training set:

   • Not explicitly stated. For an IVD device, there isn't typically a "training set" in the same sense as machine learning algorithms. The development of the assay reagents and parameters would involve extensive R&D, but specific "training set" sizes are not usually disclosed in 510(k) summaries as they are not a discrete dataset used to train an algorithm.

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

   • Not applicable, as there's no explicitly defined "training set" with ground truth in the context of an IVD like there would be for an AI algorithm. The development process would rely on established biochemical principles and extensive internal testing/optimization.

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Immunological in vitro assay for the quantitative determination of cortisol in human serum, plasma and urine. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.

The ELECSYS® Cortisol Assay a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code.

The information provided describes the Elecsys® Cortisol Assay and its substantial equivalence to a predicate device (Bayer Diagnostics ACS:180 Cortisol Assay). It focuses on comparing the new device's performance characteristics to the predicate device to demonstrate substantial equivalence, rather than detailing a specific study proving the device meets acceptance criteria with predefined thresholds. Therefore, some of the requested information cannot be fully extracted as it pertains to a typical clinical validation study with explicitly stated acceptance criteria and a detailed study design.

Here's the breakdown of what can be extracted and what is not available in the provided text:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" through specific numerical thresholds for each performance characteristic. Instead, it demonstrates performance by comparing the new device's data directly to that of the predicate device, implying that performance comparable to the legally marketed predicate device is the de facto acceptance criteria for substantial equivalence.

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For the quantitative determination of cortisol in serum using the Ciba Corning Automated Chemiluminescence Systems.

The Ciba Corning ACS Cortisol assay is a competitive chemiluminescent immunoassay. Cortisol in the patient sample competes with the acridinium ester (AE-labeled cortisol (Lite Reagent) for binding to polyclonal rabbit anti-cortisol antibody on the Solid Phase. The polyclonal rabbit anti-cortisol antibody is bound to monoclonal mouse anti-rabbit antibody, which is coupled to paramagnetic particles (solid phase). An inverse relationship exists between the amount of cortisol present in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.

The provided text describes a medical device, the Ciba Corning ACS Cortisol Immunoassay, and its performance data as part of a 510(k) summary. However, this document does not contain any information about acceptance criteria, clinical studies with human readers, or an AI device.

The document describes an immunoassay, which is a laboratory test that measures the presence or concentration of a substance (in this case, cortisol) using the reaction of an antibody to its antigen. This is a chemical/biological assay, not an AI or imaging device.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and the reported device performance: This document reports sensitivity and accuracy against predicate devices, but it doesn't define "acceptance criteria" in the context of an AI-driven device with performance metrics like specificity, sensitivity, or AUC.
• Sample size used for the test set and the data provenance: While sample sizes for accuracy studies are given (100 extracted urine samples, 70 extracted urine samples), there's no mention of a "test set" in the context of AI. Data provenance is not specified beyond "patient sample" or "extracted urine samples."
• Number of experts used to establish the ground truth... and qualifications: Not applicable as this is not an AI/imaging device requiring expert interpretation for ground truth.
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, as there are no human readers or AI in this context.
• Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• Type of ground truth used: For the accuracy section, the "ground truth" seems to be the results obtained by the predicate devices (Fluorescence Polarization Immunoassay and Radioimmunoassay).
• Sample size for the training set: Not applicable, as there is no AI model to train.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a traditional in-vitro diagnostic immunoassay. It does not contain any information related to AI, machine learning, or clinical studies involving human readers or expert consensus for ground truth, which are the core components of your request.

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