(127 days)
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.
{0}------------------------------------------------
Company Confidential
Summary of Safety and Effectiveness NCY - 5 1996
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitter Information
Contact person:
Address:
Thomas F. Flynn
June 28, 1996
Ciba Corning Diagnostics Corp. 63 North Street Medfield, MA 02052
(508) 359-3877 Phone: FAX: (508) 359-3885 thomas.flynn@cibadiag.com e-mail:
Date Summary Prepared:
2. Device Information
Proprietary Name: Common Name: Classification Name: ACS Cortisol Immunoassay Cortisol Immunoassay Class II. Cortisol Test System 21 CFR 862.1205
3. Predicate Device Information
Name:
Manufacturer: 510(k) Number:
Name: Manufacturer: 510(k) Number: Tdx® Cortisol Fluorescence Polarization Immunoassav Abbott Laboratories Not Known
COAT-A-COUNT Cortisol RadioImmunoassay Diagnostic Products Corporation Not Known
4. Device Description
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.
{1}------------------------------------------------
5. Statement of Intended Use
For the quantitative determination of cortisol in serum using the Ciba Corning Automated Chemiluminescence Systems.
6. Summary of Technological Characteristics
The Ciba Corning ACS Cortisol procedure is a competitive chemiluminescent immunoassay.
7. Performance Data
Sensitivity
The ACS Cortisol immunoassay measures cortisol concentration up to 75 ug/mL with a minimum detectable concentration of 0.20 µg/mL.
Accuracy
For 100 extracted urine samples in the range of 8.0 to 148.8 µg/24 hours, the correlation between the ACS Cortisol and the fluorescence polarization immunoassay (FPIA) method is described by the equation:
ACS Cortisol = 0.92 (FPIA) + 4.8
Correlation coefficient (r) = 0.92
For 70 extracted urine samples in the range of 13.4 to 175.1 µg/24 hours, the correlation between the ACS Cortisol immunoassay and the Radioimmunoassay (RIA) method is described by the equation:
$$\textbf{ACC} \textbf{Cost} \textbf{Cost} = \textbf{1.04} \underbrace{\textbf{\widehat{\textbf{P}} \textbf{P} \textbf{A} \textbf{\beta}}}_{\textbf{C}^{-1} \textbf{1.2}} \textbf{1.2}$$
Correlation coefficient (r) = 0.96
Image /page/1/Picture/16 description: The image shows a black circle on a white background. The circle is located on the left side of the image. The circle is solid black and has a smooth edge. The background is plain white.
§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
(a)
Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.(b)
Classification. Class II.