ELECSYS CORTISOL TEST SYSTEM

K021218 · Roche Diagnostics Corp. · JFT · Sep 9, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021218
• Device Name: ELECSYS CORTISOL TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: JFT · Clinical Chemistry
• Decision Date: Sep 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1205
• Device Class: Class 2

Intended Use

Immunological in vitro assay for the quantitative determination of cortisol in human serum, plasma and urine. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.

Device Story

ELECSYS Cortisol Assay is a two-step sandwich immunoassay using streptavidin-coated microparticles and electrochemiluminescence (ECLIA) detection. It processes human serum, plasma, or urine samples on Roche Elecsys 1010/2010 or Modular Analytics E170 immunoassay analyzers. The system uses a master calibration curve provided via reagent bar code, supplemented by a 2-point calibration performed on the instrument. The device is used in clinical laboratory settings by trained technicians. Output is a quantitative cortisol concentration value, which clinicians use to diagnose and manage adrenal gland disorders. The assay provides automated, high-precision measurement of cortisol levels, facilitating clinical decision-making for patients with suspected adrenal dysfunction.

Clinical Evidence

Bench testing only. Performance compared to predicate device via precision studies (intra-assay and inter-assay %CV), functional sensitivity, and interference testing. Intra-assay precision for urine ranged from 2.2% to 2.9% CV; inter-assay precision ranged from 1.8% to 4.7% CV. Functional sensitivity was < 0.29 µg/dl. Interference testing confirmed the assay is unaffected by specified concentrations of protein, NaCl, urea, creatinine, and glucose.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence (ECLIA) detection; streptavidin-coated microparticles. Designed for use on Roche Elecsys 1010/2010 and Modular Analytics E170 analyzers. Automated calibration via reagent bar code and 2-point calibration. Measuring range: 1.0 - 1750 nmol/L.

Indications for Use

Indicated for the quantitative determination of cortisol in human serum, plasma, and urine to assist in the recognition and treatment of functional disorders of the adrenal gland.

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

• Bayer ACS:180 Cortisol Assay (K962559)

Submission Summary (Full Text)

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1602/218

Introduction
According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence

| Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br>Contact person: Sherri L. Coenen<br>Date prepared: April 16, 2002 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Proprietary name: ELECSYS® Cortisol Assay<br>Common name: Cortisol test<br>Classification name: Fluorometric, cortisol |
| Device<br>description | The ELECSYS® Cortisol Assay a two step sandwich immunoassay with<br>streptavidin microparticles and electrochemiluminescence detection.<br>Results are determined using a calibration curve that is generated specifically<br>on each instrument by a 2-point calibration and a master curve provided with<br>the reagent bar code. |

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| Intended use | Immunological in vitro assay for the quantitative determination of cortisol in<br>human serum, plasma and urine. |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>use | The determination of cortisol is used for the recognition and treatment of<br>functional disorders of the adrenal gland. |
| Substantial<br>equivalence | The ELECSYS Cortisol test is equivalent to other devices legally marketed in<br>the United States. We claim equivalence to the Bayer Diagnostics ACS:180<br>Cortisol Assay (K962559). |

.

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Substantial The following table compares the ELECSYS® Cortisol, with the Predicate equivalence -Devices. similarities

| Feature | New Device<br>ELECSYS Cortisol | Predicate Device<br>Bayer ACS:180 Cortisol |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Immunological in vitro assay<br>for the quantitative<br>determination of cortisol in<br>human serum, plasma, and<br>urine. The determination of<br>cortisol is used for the<br>recognition and treatment of<br>functional disorders of the<br>adrenal gland.<br><br>The electrochemiluminescence<br>immunoassay "ECLIA" is<br>intended for use on Roche<br>Elecsys 1010/2010 and<br>Modular Analytics E170<br>(Elecsys module) immunoassay<br>analyzers. | For the quantitative<br>determination of cortisol in<br>serum or urine using the<br>Chiron Diagnostics<br>ACS:180 Automatic<br>Chemiluminescence<br>Systems.<br><br>For In Vitro Diagnostic use. |
| Sample type | serum, plasma, urine | serum, urine |
| Assay Protocol | competition assay | competition assay |
| Detection<br>Protocol | electrochemiluminescence | direct chemiluminescence |

The following table compares the ELECSYS® Cortisol with the Predicate Substantial equivalence – Device. differences

| Feature | New Device<br>ELECSYS Cortisol | Predicate Device<br>Bayer ACS:180 Cortisol |
|-----------------|--------------------------------|-----------------------------------------------|
| Measuring range | 1.0 - 1750 nmol/L | 5.5 - 2069 nmol/L |
| Expected values | Urine<br>36 - 137 ug/24 hrs | Urine<br>12.1 - 103.8 ug/24 hrs |
| Instrument | Elecsys immunoassay analyzers | ACS:180 automated<br>chemiluminescence system |

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Substantial equivalence performance

The performance characteristics of the ELECSYS Cortisol and the Predicate Device are compared in the table below.

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characteristics

| Feature | New Device<br>ELECSYS Cortisol | Predicate Device<br>Bayer ACS:180 Cortisol |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Intra-assay<br>precision (%CV) | Urine<br>• 2.2% at 22.3 µg/dl<br>• 2.3% at 33.2 µg/dl<br>• 2.9% at 41.9 µg/dl<br>• 2.3% at 61.0 µg/dl | • 5.7% at 3.04 µg/dl<br>• 5.1% at 5.43 µg/dl<br>• 4.5% at 14.90 µg/dl<br>• 6.4% at 18.98 µg/dl<br>• 7.0% at 31.79 µg/dl<br>• 7.5% at 38.67 µg/dl |
| Interassay<br>precision (%CV) | Urine<br>• 2.5% at 23.2 µg/dl<br>• 3.2% at 33.4 µg/dl<br>• 2.5% at 42.1 µg/dl<br>• 1.8% at 58.9 µg/dl<br>Control<br>• 4.7% at 2.82 µg/dl | N/A |
| Total precision<br>(%CV) | N/A | • 9.1% at 3.04 µg/dl<br>• 8.0% at 5.43 µg/dl<br>• 6.4% at 14.90 µg/dl<br>• 8.2% at 18.98 µg/dl<br>• 9.2% at 31.79 µg/dl<br>• 9.7% at 38.67 µg/dl |

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Substantial equivalence performance characteristics, continued

The performance characteristics of the ELECSYS Cortisol and the Predicate Device are compared in the table below.

| Feature | New Device | Predicate Device |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional<br>sensitivity | ELECSYS Cortisol | Bayer ACS:180 Cortisol |
| | < 0.29 µg/dl | 0.2 µg/dl |
| Limitations | When performed in urine, the<br>assay is unaffected by:<br>60 mg/dl protein 750 mmol/l NaCl 350 mmol/l urea 5 mmol/l creatinine 2 mmol/l glucose | When performed in urine, the<br>assay is unaffected by:<br>60 mg/dl protein 750 mmol/l NaCl 350 mmol/l urea 5 mmol/l creatinine 2 mmol/l glucose |
| On-board<br>stability | Elecsys® 2010 / E170: 6 weeks Elecsys® 1010: 6 weeks<br>(stored alternately in refrigerator and analyzer at<br>ambient temperature 20-25 C) Up to 20 hr. opened in total | until expiration date on the vial<br>label or cumulative 32 hrs at<br>room temperature. |

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Substantial equivalence performance characteristics, continued

The performance characteristics of the ELECSYS Cortisol and the Predicate Device are compared in the table below.

| Feature | New Device | Predicate Device |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ELECSYS Cortisol | Bayer ACS:180 Cortisol |
| Calibration<br>frequency | Elecsys® 2010 / E170:<br>• Once per reagent lot<br>• after one month (using<br>the same reagent lot)<br>• after 7 days (using the<br>same reagent kit on the<br>analyzer)<br>Elecsys® 1010<br>• With every reagent kit<br>• after 7 days (using the<br>same reagent kit,<br>ambient temperature 20<br>- 25°C)<br>• after 3 days (using the<br>same reagent kit,<br>ambient temperature 25<br>- 32°C)<br>• Controls out of range (both<br>systems) | • every 7 days<br>• when changing lot<br>numbers of assay reagents<br>• when replacing system<br>components<br>• when quality control<br>results are repeatedly out<br>of range |

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a stylized bird-like shape representing the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

ood and Drug Administratio 2098 Gaither Road Rockville MD 20850

Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

9 2002 SEP

Re: k021218 Trade/Device Name: ELECSYS® Cortisol Test System Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system Regulatory Class: Class II Product Code: JFT Dated: July 19, 2002 Received: July 23, 2002

Dear Ms. Coenen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours.

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): N/A

Device Name: ELECSYS® Cortisol Test System

Indications For Use:

Immunological in vitro assay for the quantitative determination of cortisol in human serum, plasma and urine. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021218

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-

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