AXSYM CORTISOL ASSAY

K033731 · Fujirebio Diagnostics,Inc. · JFT · Feb 20, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033731
• Device Name: AXSYM CORTISOL ASSAY
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JFT · Clinical Chemistry
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1205
• Device Class: Class 2

Intended Use

The AxSYM® Cortisol assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of Cortisol in human serum, plasma or urine on the AxSYM® System to aid in the diagnosis and treatment of adrenal disorders.

Device Story

The AxSYM Cortisol assay is an in vitro diagnostic test performed on the AxSYM System. It uses Fluorescence Polarization Immunoassay (FPIA) technology to measure cortisol levels in human serum, plasma, or urine. The process involves automated pipetting of samples, cortisol antiserum, pretreatment solution, and a cortisol fluorescein tracer into a reaction vessel. Cortisol from the sample and the tracer compete for binding sites on the antibody. The system's FPIA optical assembly measures the intensity of polarized fluorescent light. The resulting quantitative measurement aids clinicians in diagnosing and treating adrenal disorders. The assay is intended for use in a clinical laboratory setting by trained laboratory personnel.

Clinical Evidence

Bench testing only. Reproducibility evaluated per NCCLS EP5-A protocol over 20 days using three reagent lots and two instruments; total precision %CV ≤ 15.0. Method comparison study performed on 130 serum/plasma and 150 urine specimens against a competitor assay. Serum/plasma correlation (r=0.96) and urine correlation (r=0.98) reported via Passing-Bablok regression. Normal range established using 50 serum and 49 urine specimens from healthy individuals.

Technological Characteristics

Fluorescence Polarization Immunoassay (FPIA) technology. Utilizes cortisol antiserum, pretreatment solution, and cortisol fluorescein tracer. Automated processing on the AxSYM System. Quantitative measurement via polarized fluorescent light intensity. No specific materials of construction or connectivity standards provided.

Indications for Use

Indicated for the quantitative measurement of cortisol in human serum, plasma, or urine to aid in the diagnosis and treatment of adrenal disorders. For prescription use.

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

• Beckman Access® Cortisol assay

Submission Summary (Full Text)

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FEB 2 0 2004

# 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: __ ____________________________________________________________________________________________________________________________________________

# Submitter Information

| Address: | Fujirebio Diagnostics, Inc.<br>201 Great Valley Parkway<br>Malvern, PA 19355 |
|---------------------------|------------------------------------------------------------------------------|
| Contact person: | Kimberly Peterson, [phone] |
| Summary preparation date: | November 26, 2003 |
| Name of Device | |
| Trade/Proprietary Name: | AxSYM® Cortisol assay |
| Common/Usual Name: | Cortisol Assay |
| Classification Name: | Cortisol (hydrocortisone and hydroxycorticosterone) tes<br>system |

# Predicate Device

Beckman Access® Cortisol assay

# Device Description

The AxSYM Cortisol assay utilizes Fluorescence Polarization Immunoassay (FPIA) The AxSYM Cortisol Reagents and sample are pipetted in the following technology. sequence:

- · Sample and all AxSYM Cortisol Reagents required for one test are pipetted by the sampling probe into various positions of a Reaction Vessel (RV).
- Sample, the Cortisol Antiserum (antibody), pretreatment solution and Solution 4 (Line . Diluent) are pipetted into one well of the RV.
- · Additional pretreatment solution 4 (Line Diluent) are pipetted to the cuvette of the RV.

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- · The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.
In the processing center, an aliquot of the predilution mixture and Solution 4 (Line Diluent) are transferred to the cuvette of the RV and the blank intensity of the sample is measured. A second aliquot of the predilution mixture is transferred to the cuvette along with the Cortisol Fluorescein Tracer. Cortisol from the sample and the Cortisol Fluorescein Tracer compete for binding sites on the antibody molecule. The intensity of polarized fluorescent light is measured by the FPIA optical assembly.

## Intended Use

The AxSYM® Cortisol assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of Cortisol in human serum, plasma or urine on the AxSYM® System to aid in the diagnosis and treatment of adrenal disorders.

## Summary of Performance characteristics

#### Reproducibility:

Precision was determined as described in the National Committee for Clinical Laboratory Standards (NCCLS) Protocol EP5-A. Three buffer-based panel members (1, 2, and 3) were assayed, in replicates of two, at two separate times per day, for 20 days. Three reagent lots were tested using two instruments, with a single standard calibration per reagent pack. The total precision was determined by calculating the standard deviation (SD) and percent coefficient of variation (%CV) values for each sample.

The total precision %CV of the AxSYM® Cortisol assay was determined to be less than or equal to 15.0.

#### Comparison Study

A total of 130, endogenous and cortisol-spiked serum and sodium heparin plasma specimens and 150, endogenous and cortisol-spiked urine specimens were tested using the AxSYM Cortisol assay and a Competitor Cortisol assay. Least squares and Passing-Bablok linear regression analyses were performed on all specimens with concentration values within the dynamic range of both assays (0 - 60ug/dL for the both the AxSYM and the Competitor Cortisol assavs).

Least squares linear regression analysis comparing the AxSYM® Cortisol assay to the Beckman Access® Cortisol assay for serum and plasma yielded a correlation coefficient of 0.96, a slope of 0.87 and Y-axis intercept of - 0.74. Least squares linear regression analysis for urine vielded a correlation coefficient of 0.79 and Y-axis intercept of - 0.59.

Passing-Bablok linear regression analysis comparing the AxSYM Cortisol assay to the Beckman Access Cortisol assay for serum and plasma vielded a correlation coefficient of

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0.96, a slope of 0.93, and Y-axis intercept -2.39. Passing-Bablok linear regression analysis for urine yielded a correlation coefficient of 0.98, a slope of 0.79, and Y-axis intercept -0.48.

# Expected Values:

A study was conducted to establish the normal range for a given population using the AxSYM® Cortisol assay. A total of 50 serum (AM and PM collections) and 49 urine (24 hour collection) specimens from apparently healthy individuals were evaluated using the AxSYM® Cortisol assay.

In the population tested, the 95% confidence limit for the normal range of AM and PM cortisol in the serum specimens was determined to be 4.2 to 38.4 µg/dL (median value 10.8 µg/dL) and 1.7 to 16.6 ug/dL (median value 6.7 ug/dL) respectively. It is recommended that each laboratory establish its own range.

The 95% confidence limit for the normal range of cortisol in urine specimens was determined to be 32 to 243 µg/24 hour (median value 88 µg/24 hours). It is recommended that each laboratory establish its own range.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 0 2004

Ms. Kimberly M. Peterson Manager, Regulatory Affairs Fuiirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355

k033731 Re:

Trade/Device Name: AxSYM® Cortisol assay Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system Regulatory Class: Class II Product Code: JFT; JIT; JJX Dated: November 26, 2003 Received: December 15, 2003

Dear Ms. Peterson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your we 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 conniered pror to ritle) 2011-11-11, accordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , are expressions 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 may or babyer to back 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 r lease be devilsed that i bromination that your device complies with other requirements of the Act that I Dr. I has matures 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) I his lotter will and in yourse 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, If you desire specific 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 Tour may 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/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Yean 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 STATEMENT

510(k) Number (if known): K033731

Page _1_ of _1_

Device Name: AxSYM® Cortisol assay

The AxSYM® Cortisol assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of Cortisol in human serum, plasma or urine on the AxSYM® System to aid in the diagnosis and treatment of adrenal disorders.

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Concurence of CDRH, Office of Device Evaulation (ODE)

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Carol Benson
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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)K033731

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