ACS CORTISOL IMMUNOASSAY

K962559 · Ciba Corning Diagnostics Corp. · JFT · Nov 5, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962559
• Device Name: ACS CORTISOL IMMUNOASSAY
• Applicant: Ciba Corning Diagnostics Corp.
• Product Code: JFT · Clinical Chemistry
• Decision Date: Nov 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1205
• Device Class: Class 2

Intended Use

For the quantitative determination of cortisol in serum using the Ciba Corning Automated Chemiluminescence Systems.

Device Story

ACS Cortisol Immunoassay is a competitive chemiluminescent immunoassay for serum cortisol quantification. Input: patient serum sample. Principle: cortisol in sample competes with acridinium ester-labeled cortisol (Lite Reagent) for binding to polyclonal rabbit anti-cortisol antibody; antibody is bound to monoclonal mouse anti-rabbit antibody coupled to paramagnetic particles (solid phase). Output: relative light units (RLUs) detected by ACS:180 system; inverse relationship between cortisol concentration and RLUs. Used in clinical laboratory settings by trained technicians. Output used by clinicians to assess cortisol levels, aiding in diagnosis of adrenal function disorders.

Clinical Evidence

Bench testing only. Accuracy evaluated using 100 extracted urine samples compared to FPIA (r=0.92) and 70 extracted urine samples compared to RIA (r=0.96). Sensitivity: minimum detectable concentration 0.20 µg/mL; measurement range up to 75 µg/mL.

Technological Characteristics

Competitive chemiluminescent immunoassay. Reagents: acridinium ester-labeled cortisol, polyclonal rabbit anti-cortisol antibody, monoclonal mouse anti-rabbit antibody, paramagnetic particles. Detection: chemiluminescence (RLUs). Platform: ACS:180 Automated Chemiluminescence System.

Indications for Use

Indicated for the quantitative determination of cortisol in serum for clinical diagnostic purposes.

Regulatory Classification

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.

Predicate Devices

• Tdx® Cortisol Fluorescence Polarization Immunoassay (Not Known)
• COAT-A-COUNT Cortisol RadioImmunoassay (Not Known)

Submission Summary (Full Text)

{0}

Company Confidential
K962559

# 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: Thomas F. Flynn

Address: Ciba Corning Diagnostics Corp.
63 North Street
Medfield, MA 02052

Phone: [phone]
FAX: [phone]
e-mail: [e-mail]

Date Summary Prepared: June 28, 1996

## 2. Device Information

Proprietary Name: ACS Cortisol Immunoassay
Common Name: Cortisol Immunoassay
Classification Name: Class II, Cortisol Test System
21 CFR 862.1205

## 3. Predicate Device Information

Name: Tdx® Cortisol Fluorescence Polarization Immunoassay
Manufacturer: Abbott Laboratories
510(k) Number: Not Known

Name: COAT-A-COUNT Cortisol RadioImmunoassay
Manufacturer: Diagnostic Products Corporation
510(k) Number: 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.

Acs Cortisol 510(k) Notification
June 28, 1996
CORTSS&E.DOC

{1}

Company Confidential
k962559

## 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 µg/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:

$$
\text{ACS Cortisol} = 0.92 \ (\text{FPIA}) + 4.8
$$

$$
\text{Correlation coefficient (r)} = 0.92
$$

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:

$$
\text{ACS Cortisol} = 1.04 \ (\text{FPIA}) - 1.2
$$

$$
\text{Correlation coefficient (r)} = 0.96
$$

Acs Cortisol 510(k) Notification
June 28, 1996
CORTSS&E.DOC