CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS

K050202 · Beckman Coulter, Inc. · CGR · Feb 9, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050202
• Device Name: CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
• Applicant: Beckman Coulter, Inc.
• Product Code: CGR · Clinical Chemistry
• Decision Date: Feb 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1205
• Device Class: Class 2

Intended Use

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.

Device Story

Access Cortisol reagent system; utilizes rabbit anti-cortisol polyclonal antibody in R1b component; performs quantitative cortisol measurement in serum, plasma, and urine; used in clinical laboratory settings on Access Immunoassay Systems; provides diagnostic data for cortisol levels; modification involves new manufacturing lot of polyclonal antibody; fundamental scientific technology remains unchanged; clinical utility unaffected by antibody lot change.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and analytical performance comparisons.

Technological Characteristics

In vitro diagnostic immunoassay reagent; utilizes rabbit anti-cortisol polyclonal antibody; designed for use on Access Immunoassay Systems; fundamental technology unchanged from predicate; labeling updated for analytical specificity/interference and expected values for urine concentration.

Indications for Use

Indicated for the quantitative determination of cortisol in human serum, plasma, and urine on the Access Immunoassay Systems.

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

• Access Cortisol Assay Beckman Coulter, Inc. (k954733)

Submission Summary (Full Text)

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# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: KO50000

## Submitter's Name and Address

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: [phone] Fax: [phone] Contact: Brent Taber

Date Prepared: January 27, 2005

### Device Names

| Proprietary Name: | Cortisol and Cortisol Calibrators on the Access®<br>Immunoassay Systems |
|-------------------|-------------------------------------------------------------------------|
| Common Name: | Cortisol (hydrocortisone and hydroxycorticosterone) test system |

Classification Name: Radioimmunoassay, Cortisol

### Predicate Device

Access Cortisol Assay Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

510(k) Number: k954733

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Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two curved lines inside, resembling a stylized eye. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked on top of each other in a bold, sans-serif font.

#### Device Description

The Access Cortiosol reagents, Access Cortisol Calibrators and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine.

#### Intended Use

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.

### Comparison of Technological Characteristics

| Attribute | Access Cortisol Assay | Cortisol and Cortisol<br>Calibrators on the Access<br>Immunoassay Systems |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Competitive binding<br>immunoenzymatic assay | Competitive binding<br>immunoenzymatic assay |
| Intended Use | Quantitative determination of<br>cortisol levels in human serum,<br>plasma (heparin, EDTA) and<br>urine | Quantitative determination of<br>cortisol levels in human serum,<br>plasma (heparin, EDTA) and<br>urine |
| Solid Phase | Paramagnetic particles coated<br>with goat anti-rabbit IgG | Paramagnetic particles coated<br>with goat anti-rabbit IgG |
| Conjugate | Cortisol-alkaline phosphatase<br>(bovine) conjugate | Cortisol-alkaline phosphatase<br>(bovine) conjugate |
| Calibrators | Human serum containing<br>cortisol (purified chemical<br>compound) at levels of 0 and<br>approximately 2, 5, 10, 25, and<br>60 ug/dL | Human serum containing<br>cortisol (purified chemical<br>compound) at levels of 0 and<br>approximately 2, 5, 10, 25, and<br>60 ug/dL |

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Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle on the left, with two curved white lines running through it. To the right of the circle are the words "BECKMAN" stacked on top of "COULTER", both in a bold, sans-serif font. The logo is simple and modern, and the use of black and white gives it a clean and professional look.

#### Summary of Technological Characteristics

The device modification consists of a change to the directional insert. Crossreactivity of the assay with substances that are similar in structure to cortisol was revised in the 'Analytical Specificity / Interferences' section. Urine cortisol concentration in 24-hour urine samples determined by extracted and unextracted methods was revised in the 'Expected Values' section.

#### Conclusion

Cortisol and Cortios Calibrators on the Access Immunoassay Systems is substantially equivalent to the Access Cortisol assay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine.

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#### Indications for Use Statement C.

The indications for use statement appears on the following page.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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FEB - 9 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Brent Taber Staff Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084

Re: k050202

Trade/Device Name: Cortisol and Cortisol Calibrators on the Access® Immunoassay Systems Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system Regulatory Class: Class II Product Code: CGR, JIS Dated: January 27, 2005 Received: January 28, 2005

Dear Mr. Taber:

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 Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours,

Sean M. Cooper MS, DUM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): k050202

Cortisol and Cortisol Calibrators on the Device Name: Access® Immunoassay Systems

Indications For Use:

The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the guantitative 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benen
Division Sign-Off

Office of in Vita Diagnostic Device Evaluation and Safety

51092 K050202

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