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510(k) Data Aggregation
(223 days)
Access Cortisol; DxC 500i Clinical Analyzer
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
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison | Slope criteria of 1.00 ± 0.12 (using Weighted Deming regression analysis when compared to predicate device) | Serum: Slope = 0.974 (95% CI: 0.952 - 0.996) |
| Urine: Slope = 1.002 (95% CI: 0.976 - 1.029) | ||
| Linearity | Linear throughout the analytical measuring range. | Determined to be linear throughout the analytical measuring range (2.3 - 60.0 µg/dL). |
| Imprecision (Repeatability & Total) | Allowable imprecision of |
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(132 days)
Access Cortisol
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:
| Performance Parameter | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Method Comparison | R2 ≥ 0.90, Slope 1.00 ± 0.12 | Correlation Coefficient (R2): 1.00 (meets criteria) |
| Slope: 1.01 (falls within 0.88 - 1.12 range, meets criteria) | ||
| Slope 95% CI: 0.99 - 1.03 | ||
| Intercept: -0.20 | ||
| Intercept 95% CI: -0.41 - 0.056 | ||
| (N=116 samples, concentration range 1.6 - 59 ug/dL) | ||
| Imprecision | Within-laboratory (total) %CV: ≤ 9.3% for levels > 5.0 ug/dL; SD ≤ 0.1 for levels ≤ 5.0 ug/dL (based on reported performance meeting target, specific criteria not explicitly stated but implied by acceptable results) | Within-laboratory (total) %CV: |
| Sample 1 (0.90 ug/dL): 13.1% (SD 0.1) - Note: This sample has a higher %CV than 9.3% for a low concentration, but the SD of 0.1 meets the low concentration criteria. | ||
| Sample 2 (5.7 ug/dL): 7.1% | ||
| Sample 3 (19 ug/dL): 8.6% | ||
| Sample 4 (29 ug/dL): 9.3% | ||
| Sample 5 (49 ug/dL): 3.9% | ||
| All other samples meet the stated criteria for %CV or SD. (80 replicates per sample across 20 days, 3 analyzers, 3 reagent lots, 3 calibrator lots) | ||
| Linearity | Non-linearity within ± 1 ug/dL for values ≤ 5.0 ug/dL and ± 20% for values > 5.0 ug/dL | Meets acceptance criteria, linear across 0.8 - 60 ug/dL. |
| Limit of Blank (LoB) | 0.4 ug/dL | Assay designed to meet claimed LoB of 0.4 ug/dL. |
| Limit of Detection (LoD) | 0.4 ug/dL | Assay designed to meet claimed LoD of 0.4 ug/dL. |
| Limit of Quantitation (LoQ) | 0.8 ug/dL (based on 20% CV) | LoQ designed to meet claimed LoQ of 0.8 ug/dL. |
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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