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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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The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in serum, plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a single instrument presentation. The system is for in vitro diagnostic use only.

The chemistry module of the DxC 500i Clinical Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (OC) material and other accessories. The immunoassay module of the DxC 500i Clinical Analyzer is an in-vitro diagnostic device used for the quantitative, semiquantitative, or qualitative determination of various analyte concentrations found in human body fluids.

The Access Cortisol assay is a competitive binding immuno-enzymatic assay designed for use on Beckman Coulter's Access immunoassay analyzers in a clinical laboratory setting.

The DxC 500i Clinical Analyzer is an integrated chemistry-immunoassay work cell that combines Beckman Coulter's DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a single instrument presentation. The DxC 500i instrument has a single user interface and common point of entry for sample racks; the sample handling unit operates as a parallel processor and sample manager for both sides of the instrument. The DxC 500i operates in conjunction with the existing reagents, calibrators, controls, and system solutions for the AU and Access instrument families.

The provided text describes the Beckman Coulter Access Cortisol assay on the DxC 500i Clinical Analyzer and its comparison to a predicate device. Here's a breakdown of the acceptance criteria and study information:

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

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The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.

A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in serum, plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

The Access Cortisol assay is a competitive binding immunoenzymatic assay. The Access Cortisol reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include Calibrators, substrate, and wash buffer. The Access Cortisol assay reagent pack, Access Cortisol assay calibrators, along with the UniCel Dxl wash buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

The provided text is a 510(k) Summary for the Beckman Coulter Access Cortisol Assay, intended for in vitro diagnostic use. It describes the device, its intended use, and comparative studies to demonstrate substantial equivalence to a predicate device.

Key points regarding acceptance criteria and study data fulfillment:

This document is for an in vitro diagnostic (IVD) device, not an AI/ML-based device for image analysis. Therefore, many of the requested criteria (e.g., number of experts for ground truth, MRMC study, human-in-the-loop performance, training set details) are not applicable to this type of medical device submission. The acceptance criteria and studies for IVD devices focus on analytical performance parameters.

Here's an analysis of the existing information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Method Comparison: N=116 samples. Data provenance is not specified (e.g., country of origin, retrospective/prospective), but implied to be from an internal site.
• Imprecision: 5 serum samples were used, with 80 replicates per sample (total 400 measurements). Data provenance is from "one internal site."
• Linearity, LoB/LoD, LoQ: Sample sizes are not explicitly stated for these studies, but they are performed as verification studies following CLSI guidelines. Data provenance is implied to be from an internal site.

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

• Not Applicable. This is an IVD device for quantitative determination of a biomarker (cortisol) in patient samples. The "ground truth" is established by the analytical method itself and its traceability to a reference material (USP Reference Material for cortisol). There are no human experts "establishing ground truth" in the way it would be for an AI-based imaging device interpreting images.

4. Adjudication Method for the Test Set:

• Not Applicable. As per point 3, there is no expert adjudication for an IVD assay's analytical performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is an IVD device measuring a biomarker, not an AI/ML-based device assisting human readers in interpreting medical images. MRMC studies are not relevant for this type of device.

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

• Yes, implicitly. The analytical performance studies (Method Comparison, Imprecision, Linearity, LoB/LoD, LoQ) evaluate the device (Access Cortisol Assay on Dxl 9000 Access Immunoassay Analyzer) in a standalone capacity, i.e., its ability to accurately and precisely measure cortisol levels. There is no "human-in-the-loop" aspect to the primary function of this diagnostic assay.

7. The Type of Ground Truth Used:

• The ground truth is established by:
  • Reference Method/Predicate Device: For method comparison, the predicate Access Cortisol assay on the Access Immunoassay System serves as the comparative "reference."
  • Traceability to Reference Material: The calibrators and the assay itself are traceable to USP Reference Material for cortisol. This is the ultimate "ground truth" for the accuracy of the cortisol measurements.
  • Defined Concentrations/Spiked Samples: For linearity and LoB/LoD/LoQ studies, samples with known or spiked concentrations are used.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning. The device is a chemiluminescent immunoassay; its analytical characteristics are determined by its chemical and biological components and the instrument's engineering.

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

• Not Applicable. As per point 8, there is no "training set" or corresponding "ground truth" establishment in the AI/ML sense for this device.

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The IDS Cortisol assay is an in vitro diagnostic device intended for the quantitative determination of cortisol in human serum and plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to assist clinicians in the diagnosis and treatment of disorders of the adrenal gland.

The IDS Cortisol assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents:

• MPE1:Magnetic particles coated rat anti-mouse monoclonal antibody in a phosphate buffer with Proclin as preservative.
• CONJ: Cortisol coupled with an acridinium ester derivative in = phosphate buffer with Proclin as a preservative.
• mAb: Mouse anti-cortisol monoclonal antibody in phosphate buffer with Proclin as a preservative .;
• BUF: HEPES buffer containing Proclin as preservative .

This document describes the analytical performance of the IDS Cortisol assay, an in vitro diagnostic device, and demonstrates its substantial equivalence to a predicate device (Roche Elecsys Cortisol II). The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this in vitro diagnostic device are primarily based on demonstrating analytical performance that is comparable to, or meets specified standards relative to, established laboratory methods and a predicate device.

• 0.94 µg/dL: 7.8% CV
• 1.84 µg/dL: 4.6% CV
• 5.75 µg/dL: 2.4% CV
• 13.06 µg/dL: 2.4% CV
• 19.94 µg/dL: 1.8% CV
• 44.63 µg/dL: 1.9% CV
  |
  | | Intermediate Precision (Within-System/Total): Lower CV% | Within-System (n=80 per sample, 1 lot, 1 system):
• 0.94 µg/dL: 16.2% CV
• 1.84 µg/dL: 10.9% CV
• 5.75 µg/dL: 5.2% CV
• 13.06 µg/dL: 3.9% CV
• 19.94 µg/dL: 5.1% CV
• 44.63 µg/dL: 4.2% CV
  Total (Combind 3 lots, 3 systems, n=240 per sample):
• 0.88 µg/dL: 15.3% CV
• 1.78 µg/dL: 10.1% CV
• 5.75 µg/dL: 4.5% CV
• 13.09 µg/dL: 3.3% CV
• 20.22 µg/dL: 4.8% CV
• 44.48 µg/dL: 5.0% CV |
  | Linearity/Reportable Range | Data should demonstrate linearity across the claimed measuring range. | Measuring Range: 0.59 to 45.00 µg/dL.
  Regression: Observed = 1.01 * Expected + 0.01 µg/dL; R²: 1.00
  (Accepted based on R² close to 1 and slope ~1, intercept ~0) |
  | Detection Limits (LoB, LoD, LoQ) | Specific quantifiable low limits. | LoB: 0.10 µg/dL
  LoD: 0.24 µg/dL
  LoQ: 0.59 µg/dL |
  | Analytical Specificity (Interference) | Non-significant bias (

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For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers — for the quantitative measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.

The IMMULITE 2000 Cortisol assay is comprised of the following components: Cortisol Bead Pack (solid phase) containing Polyclonal rabbit anti-cortisol antibody; Cortisol Reagent Wedge (liquid phase) containing Alkaline phosphatase (bovine calf intestine) conjugated to cortisol in buffer, with preservative; and Cortisol Adjustors (Low and High) containing Cortisol in processed human serum, with preservative.

The provided document describes the IMMULITE® 2000 Cortisol device, a chemiluminescence immunoassay for the quantitative measurement of cortisol in serum, used as an aid in the clinical assessment of adrenal status. This submission (K202826) is for a modified device due to a new supplier of the antibody, with the predicate device being the IMMULITE® 2000 Cortisol (K931409).

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

Executive Summary:

The study aims to demonstrate substantial equivalence of the modified IMMULITE® 2000 Cortisol assay to the predicate device. The performance characteristics evaluated included detection limits, linearity, precision, spike recovery, method comparison, and analysis of interfering and cross-reactive substances. All evaluated studies produced acceptable results compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for each performance characteristic in a quantifiable manner (e.g., "linearity must have an R-squared > 0.98"). Instead, it states that the studies "produced acceptable results when compared to the Predicate device and were deemed verified" or that information "has not changed and are as per K931409." For method comparison, a regression equation and correlation coefficient are provided.

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

• Method Comparison:

  • Sample Size: 149 native patient samples.
  • Data Provenance: Not explicitly stated, but "native patient samples" implies clinical samples, likely from a hospital or lab. Retrospective or prospective is not specified. Country of origin not specified.

• Linearity:

  • Sample Size: Not explicitly stated as a number of unique patient samples, but 9 levels of dilutions were prepared from high and low human serum pools.
  • Data Provenance: Human serum pools. Retrospective or prospective, and country of origin are not specified.

• Specificity (Cross-Reactivity):

  • Sample Size: Not explicitly stated, but multiple cross-reactant solutions were prepared and spiked into "a blank sample (charcoal-adsorbed human serum)."
  • Data Provenance: Charcoal-adsorbed human serum.

• Interference:

  • Sample Size: 5 patient samples.
  • Data Provenance: Not explicitly stated, but "patient samples" implies clinical samples. Retrospective or prospective, and country of origin are not specified.

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

This information is not provided in the document. For in vitro diagnostic assays measuring specific analytes, the "ground truth" is typically the measured value itself, often established by a validated reference method or the predicate device, rather than expert interpretation of images or clinical findings.

4. Adjudication Method for the Test Set:

This is not applicable in the context of an in vitro diagnostic assay like this. Adjudication methods (e.g., 2+1, 3+1) are common in studies involving subjective assessments, such as imaging interpretation by multiple readers. For quantitative measurements, the "truth" is typically derived from the measurement itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is an in vitro diagnostic assay, not an AI or imaging device that assists human readers.

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

This is not applicable. The device is a laboratory instrument (IMMULITE® 2000 System Analyzers) that performs a chemiluminescent immunoassay. It does not involve a "standalone algorithm" in the same sense as an AI diagnostic software. Its performance is inherent to the assay and instrument.

7. The Type of Ground Truth Used:

For this type of in vitro diagnostic device, the "ground truth" is established by:

• Reference Methods/Predicate Device: For method comparison, the "truth" is implicitly the values obtained from the predicate device (unmodified IMMULITE® 2000 Cortisol assay).
• Known Concentrations: For linearity, detection limits, specificity, and interference studies, the "ground truth" is based on precisely prepared samples with known concentrations of cortisol, cross-reactants, or interferents, or "spiked" samples where the added amount is known. These are often prepared from certified reference materials or highly pure substances.

8. The Sample Size for the Training Set:

This is not applicable. This is an immunoassay device, not a machine learning or AI model that requires a "training set" in the conventional sense. The development and optimization of the assay chemistry, reagents, and instrument operation are based on laboratory experiments and validation processes, not data training.

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

This is not applicable as there is no "training set" for this type of device. The accuracy of the assay is established through extensive analytical validation using prepared controls, reference materials, and patient samples compared against established methods.

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For in vitro diagnostic use with the IMMULITE® and IMMULITE 1000 Analyzers - for the quantitative measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.

The IMMULITE/IMMULITE® 1000 Cortisol assay is comprised of the following components: Cortisol Test Unit (solid phase) - 1 bead/Test unit, Polyclonal rabbit anti-cortisol antibody. Cortisol Reagent Wedge (liquid phase) - 7.5 mL, Alkaline phosphatase (bovine calf intestine) conjugated to cortisol in buffer, with preservative. Cortisol Adjustors (Low and High) - 3 mL, Cortisol in processed human serum, with preservative.

The document describes the performance characteristics of the IMMULITE/IMMULITE® 1000 Cortisol assay, which is an in vitro diagnostic device. This device measures cortisol in serum to aid in the clinical assessment of adrenal status. The submission is for a modified device with a new supplier for the antibody, maintaining the same intended use.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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

The document doesn't explicitly present a table labeled "acceptance criteria." Instead, it describes performance characteristics that were evaluated to demonstrate substantial equivalence to a predicate device. The implied acceptance criterion for each characteristic is that the performance of the modified device should be comparable to or within acceptable limits of the predicate device, or meet established clinical laboratory standards (e.g., CLSI guidelines).

Here's a table based on the provided "Performance Characteristics" section, showing the evaluated parameters and their reported outcomes:

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

• Detection Limits (LoB, LoD, LoQ): The sample sizes are not explicitly stated for the determination of LoB, LoD, and LoQ, but these are typically determined using multiple replicates of blank and low-concentration samples. The study was conducted in accordance with CLSI EP17-A2.
• Linearity: The study involved combining a high human serum pool with a low human serum pool to create 9 levels of dilutions. The number of individual samples within these pools is not specified. The provenance is "human serum."
• Method Comparison:
  • Sample Size: A total of 152 native patient samples.
  • Data Provenance: "native patient samples," indicating human origin. The country of origin is not specified, but the applicant's address is in the UK. The study was retrospective or prospective is not explicitly stated, but "patient samples" typically implies retrospectively collected samples for this type of comparison study.

3. 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 (IVD) assay measuring a biomarker (cortisol). The "ground truth" for such devices is established by reference methods or validated higher-order methods, not typically by expert human interpretation (like in imaging AI).

• For Method Comparison, the ground truth is simply the measurement obtained from the predicate device (unmodified IMMULITE 1000 Cortisol Assay), which is presumed to be the accepted standard. No human experts are used for ground truth establishment in this context.
• For Detection Limits, Linearity, Specificity, and Interference, the ground truth is based on the precise preparation of known concentrations of analytes, cross-reactants, or interfering substances, and comparison to the assay's ability to accurately measure them. This does not involve expert human interpretation.

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

Not applicable. As an IVD assay measuring a quantitative biomarker, adjudication by human experts is not part of the ground truth establishment or performance evaluation process. The measurements are objective.

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 not an AI-assisted diagnostic imaging device for human interpretation, but rather an automated in vitro diagnostic assay measuring a chemical compound. Therefore, MRMC studies are not relevant.

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

Yes, the performance characteristics described are indeed standalone performance of the device (IMMULITE/IMMULITE® 1000 Cortisol assay) itself. It evaluates the accuracy, precision, limits, and specificity of the biochemical measurement system, without human involvement in the direct measurement or interpretation of the assay's output for diagnostic purposes in the study. The human role is in operating the instrument and interpreting the numerical result in the clinical context, but the study focuses on the analytical performance of the device.

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

The ground truth used for this IVD device is primarily:

• Reference measurements/Predicate device measurements: For the method comparison study, the measurements from the legally marketed predicate device (IMMULITE/IMMULITE® 1000 Cortisol, K931409) serve as the reference or "ground truth" for comparison.
• Prepared known concentrations: For studies like linearity, detection limits, specificity (cross-reactivity), and interference, the ground truth is established by preparing samples with precisely known concentrations of the analyte, cross-reactants, or interfering substances.
• Standardized methods/guidelines: Compliance with CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP17-A2, EP06-A, EP09c, EP07) implies that the ground truth methodology follows accepted laboratory standards for analytical performance.

8. The sample size for the training set:

Not applicable. This document describes a traditional in vitro diagnostic immunoassay, not a machine learning or artificial intelligence algorithm that requires a "training set." The development of such assays involves chemical and biological optimization, not data-driven model training.

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

Not applicable, as there is no "training set" for this type of 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 IBL International Cortisol Saliva Luminescence Immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.

Cortisol (also known as hydrocortisone, compound F) is the main glucocorticoid in humans and is produced in the zona fasciculata of the adrenal cortex. 90 % of the circulating cortisol are bound to corticoid binding globulin (CBG, Transcortin), ca. 7 % are bound to albumin and only 1-3 % are unbound. Only the latter part represents the active form of cortisol. The free cortisol is released in saliva and is excreted via the kidneys as a small part among the metabolites of cortisol. The level of free cortisol in blood regulates mainly its secretion in the adrenal cortex in a negative feedback mechanism via CRH (corticotropin releasing hormone) in the hypothalamic region and the ACTH in the pituitary gland, but it is also affected by different situations above all by stress.

In humans, there is a physiological fluctuation of cortisol achieving the highest level in the morning and the lowest during the night. This fluctuation of cortisol plasma level is reflected in saliva normally with a peak in the first 90 minutes after waking up. The cortisol measurement is indicated in adrenal disorders. Due to the diurnal fluctuations of cortisol, a salivary sample collection is an easy method without the stress of repeated venipunctures.

Test principle:
Luminescence immunoassay based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labelled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.

Device composition:
The device is available in two sizes, 96 tests and 960 tests.

The device consists of an antibody coated 96 well Microtiter Plate, seven Standards (range 0.015 - 3.20 µg/dL, equivalent to 0.15 - 32 ng/mL calibrated to the NIST cortisol), two Controls, Enzyme Conjugate (Cortisol coupled to peroxidase), Chemiluminescence Reagent 1 and 2, 10x concentrated Wash Buffer, Adhesive Foils.

The provided document describes the IBL International Cortisol Saliva Luminescence Immunoassay, a device for in-vitro diagnostic quantitative determination of Cortisol in human saliva, intended as an aid in diagnosing and treating adrenal disorders. The device's performance was evaluated through various analytical studies and a method comparison with a predicate device.

Here's a breakdown of the requested information:

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

The document does not explicitly present a table of "acceptance criteria" separate from the "reported device performance." Instead, it describes various performance characteristics and their outcomes, implying that the achieved outcomes met the internal acceptance criteria for substantial equivalence. I will synthesize the reported performance characteristics that implicitly serve as acceptance criteria.

• 37°C: 1 week
• 18-25°C: 2 weeks
• 2-8°C: 2 weeks

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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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