(127 days)
Not Known, Not Known
Not Found
No
The device description details a standard competitive chemiluminescent immunoassay and the performance studies describe correlations with established immunoassay methods. There is no mention of AI, ML, or related concepts.
No
This device is for the quantitative determination of cortisol in serum, which is a diagnostic purpose, not a therapeutic one. It measures a substance to aid in diagnosis, rather than treating a condition.
Yes
The device is described as an "immunoassay" for the "quantitative determination of cortisol in serum". This measurement provides data used to help diagnose conditions related to cortisol levels, such as Cushing's syndrome or Addison's disease. The performance studies also refer to "Sensitivity" and "Accuracy", which are typical metrics for diagnostic assays.
No
The device description clearly outlines a competitive chemiluminescent immunoassay involving physical reagents (Lite Reagent, polyclonal rabbit anti-cortisol antibody, monoclonal mouse anti-rabbit antibody, paramagnetic particles) and a system (ACS:180®) that detects relative light units. This indicates a hardware-based assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For the quantitative determination of cortisol in serum". This clearly indicates that the device is used to analyze a biological sample (serum) outside of the body (in vitro) to provide information about a patient's health status (determining cortisol levels).
- Device Description: The description details a "competitive chemiluminescent immunoassay" that uses patient samples. This is a common method used in IVD devices for measuring substances in biological fluids.
- Performance Studies: The document includes performance studies demonstrating the device's sensitivity and accuracy in measuring cortisol in biological samples (serum and urine). This is a requirement for IVD devices to show they perform as intended.
- Predicate Devices: The mention of predicate devices (Tdx® Cortisol Fluorescence Polarization Immunoassav and COAT-A-COUNT Cortisol RadioImmunoassay) further confirms that this device falls within the category of IVD tests for cortisol.
The information provided strongly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative determination of cortisol in serum using the Ciba Corning Automated Chemiluminescence Systems.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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:
ACC Cost Cost = 1.04 P P A beta C⁻¹ 1.2 1.2
Correlation coefficient (r) = 0.96
Key Metrics
Not Found
Predicate Device(s)
Not Known, Not Known
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.