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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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The IBL Cortisol enzym linked immunosorbent assay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva.

The Cortisol ELISA kit is useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease.

Solid phase enzyme-linked immunosorbent assay (ELISA) 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 the substrate reaction the intensity of the developed color is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.

Here's an analysis of the acceptance criteria and the study proving device performance for the IBL Cortisol ELISA, based on the provided text:

Acceptance Criteria and Device Performance for IBL Cortisol ELISA

1. Table of Acceptance Criteria and Reported Device Performance

The submission document for K062626 does not explicitly state pre-defined acceptance criteria in a dedicated section. However, the performance data presented implicitly serves as the criteria the device met for clearance. Based on the "Device Performance" section, the following can be inferred as the de-facto acceptance measurements:

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The measurement of cortisol in human serum, plasma (heparin or EDTA) or urine aids in the assessment of adrenal status.

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of there main elements: The VITROS Immunodiagnostic Products range of immunoassay products in this case VITROS Immunodiagnostic Products Cortisol Reagent Pack, VITROS Immunodiagnostic Products Cortisol Calibrators (cleared under K983990) and VITROS Immunodiagnostic Products Metabolism Controls (cleared under K983990), which are combined by the VITROS Immunodiagnostic System to perform the VITROS Cortisol assay. The VITROS Immunodiagnostic System - instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919). Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

The provided text describes a 510(k) premarket notification for a medical device, the VITROS Immunodiagnostic Products Cortisol Assay. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the following information cannot be fully extracted or is not explicitly stated in the document:

• A table of acceptance criteria and the reported device performance: The document only provides a comparison of device characteristics between the new and predicate devices (Table 1) and a general statement of "equivalent performance." It does not list specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or detailed performance data against those criteria.
• Sample sized used for the test set and the data provenance: The document states that "testing human samples throughout the assay range" was done, but does not provide specific sample sizes for test sets, data provenance (e.g., country of origin), or whether the study was retrospective or prospective.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
• Adjudication method for the test set: Not provided.
• 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 an in vitro diagnostic device, not an image-based AI system that would involve human readers. Therefore, an MRMC study is not applicable or mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is an immunoassay system, not an algorithm in the context of AI. Its performance is inherent in its design and operation.
• The type of ground truth used: The document mentions "manufactured reagents, positive and negative controls and testing human samples." For an immunoassay, the 'ground truth' would typically be established by reference methods or validated clinical diagnoses/outcomes, but this is not explicitly detailed.
• The sample size for the training set: Not applicable in the context of an immunoassay for which no separate "training set" is described for an algorithm.
• How the ground truth for the training set was established: Not applicable.

Here's what can be extracted based on the provided text, focusing on the comparison to the predicate device and the general statement of performance:

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

The document does not explicitly define acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, precision, bias thresholds). Instead, "equivalent performance" to the predicate device is the overarching acceptance criterion for the 510(k) submission.

Study Proving Acceptance Criteria:

The study described is a comparison study demonstrating substantial equivalence of the modified VITROS Immunodiagnostic Products Cortisol Assay to the previously cleared predicate device (K983990). The conclusion states: "Equivalent performance was demonstrated using manufactured reagents, positive and negative controls and testing human samples throughout the assay range."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated. The document only mentions "testing human samples throughout the assay range."
• Data Provenance: Not specified (e.g., country of origin not mentioned).
• Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as this is not an image-based diagnostic or expert interpretation study. The 'ground truth' for an immunoassay's performance would typically refer to the true concentration of cortisol in samples, usually determined by reference methods or clinical gold standards. The document does not detail how this ground truth was established for the "human samples."

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

• Not applicable for this type of immunoassay study.

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. This is an in vitro diagnostic device, not an AI system.

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

• The device itself is a standalone immunoassay system. The performance evaluated is the direct output of the system. There is no concept of an "algorithm only" in the context of human-in-the-loop for this device.

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

• The document implies that performance was assessed against "manufactured reagents, positive and negative controls and testing human samples." For human samples, the ground truth for cortisol levels would typically come from a well-established reference assay or a clinically validated method, but this is not explicitly detailed.

8. The sample size for the training set

• Not applicable. This is an immunoassay, not a machine learning algorithm requiring a distinct "training set."

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

• Not applicable.

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The IBL Cortisol Luminescence Immunoassay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva.

The Cortisol LIA kit is useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease.

IBL Cortisol LIA test kit

This is an FDA Premarket Notification (510(k)) letter for the IBL Cortisol LIA test kit. The letter itself does not contain the detailed acceptance criteria or the study results. It primarily states that the device has been found substantially equivalent to a predicate device.

Therefore, I cannot provide the requested information from the provided text because it is not present in this document. The document confirms that the device is cleared for marketing but does not detail the technical performance studies and acceptance criteria that led to that clearance.

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The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the guantitative 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 Cortiosol reagents, Access Cortisol Calibrators and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine.

This document is a 510(k) summary for a device modification, specifically a change to the directional insert of the Access Cortisol assay. It does not present a new study with acceptance criteria and device performance results in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and intended use.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert qualifications, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from the provided text.

Based on the provided text, here's what can be extracted and inferred:

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

The document does not provide a table of acceptance criteria and reported device performance for a new study. Instead, it highlights revisions made to existing sections of the device's directional insert:

• Revised: 'Analytical Specificity / Interferences' section for cross-reactivity of the assay with substances similar to cortisol.
• Revised: 'Expected Values' section for urine cortisol concentration in 24-hour urine samples determined by extracted and unextracted methods.

Since this is a submission for a change in labeling (directional insert) and not a new device or significant modification requiring fresh performance studies, no new acceptance criteria or reported device performance data in the typical sense are presented. The core assay performance is presumed to be covered by the predicate device's clearance (K954733).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document describes changes to existing product information, not a new study requiring a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No new test set and ground truth were established as part of this 510(k) submission.

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

Not applicable. No new test set requiring adjudication was established.

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 device is an in-vitro diagnostic immunoassay for cortisol levels, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. This device is an in-vitro diagnostic immunoassay, not an algorithm.

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

Not applicable. The document deals with revisions to "Analytical Specificity / Interferences" and "Expected Values" for an immunoassay. The ground truth for such revisions would typically be established through biochemical and clinical studies relating to the accuracy of cortisol measurement and its physiological ranges, conducted as part of the initial device development and validation (for the predicate device). However, this document does not detail how the revised information was substantiated.

8. The sample size for the training set

Not applicable. This is not a study involving a training set for an algorithm.

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

Not applicable. This is not a study involving a training set for an algorithm.

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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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