ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE

K043175 · Roche Diagnostics Corp. · NHG · Nov 24, 2004 · Clinical Chemistry

Device Facts

• Record ID: K043175
• Device Name: ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
• Applicant: Roche Diagnostics Corp.
• Product Code: NHG · Clinical Chemistry
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1205
• Device Class: Class 2

Intended Use

The Elecsys Cortisol is an immunoassay for the in-vitro quantitative determination of cortisol in serum, plasma, urine and saliva. 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

The Elecsys Cortisol Immunoassay is a two-step sandwich immunoassay utilizing streptavidin-coated microparticles and electrochemiluminescence (ECLIA) detection. It processes human serum, plasma, urine, or saliva samples collected via Salivettes. The device is operated by laboratory personnel on Roche Elecsys 1010, 2010, or MODULAR ANALYTICS E170 analyzers. The system generates results using a 2-point calibration curve and a master curve provided via reagent bar code. Output is a quantitative cortisol concentration value. Healthcare providers use these results to screen for and manage adrenal gland functional disorders, such as Cushing's or Addison's disease. The device provides automated, high-throughput analysis compared to manual plate-reader methods, facilitating clinical decision-making regarding adrenal function.

Clinical Evidence

Bench testing only. Performance characteristics include functional sensitivity < 2.0 nmol/L (< 0.07 ug/dL) and analytical sensitivity < 0.500 nmol/L (< 0.018 ug/dL). Method comparison against the predicate using 326 samples showed a correlation of r=0.942, slope=0.90 (95% CI 0.87-0.94), and intercept=1.71 (95% CI 1.47-1.96). Precision studies reported CVs ranging from 1.5% to 7.2% for within-run and between-run measurements.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection; streptavidin-coated microparticles. Analyzers: Elecsys 1010, 2010, and MODULAR ANALYTICS E170. Calibration: 2-point calibration with reagent bar-coded master curve. Sample collection: Salivettes. Connectivity: Integrated analyzer system.

Indications for Use

Indicated for the in-vitro quantitative determination of cortisol in human serum, plasma, urine, and saliva 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

• Salimetrics HS (high sensitivity) Salivary Cortisol Enzyme (K011323)

Submission Summary (Full Text)

{0}------------------------------------------------

# K043175

NOV 2 4 2004

## 510(k) Summary

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Roche Diagnostics Submitter name, address, 9115 Hague Road contact Indianapolis, IN 46250 [phone] Contact Person: Kay A. Taylor Device Name Proprietary name: Elecsys® Cortisol Immunoassay System Common name: Cortisol Test Classification name: Fluorometic, cortisol The Elecsys Cortisol Assay is a two step sandwich immunoassay with Device Description streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. Intended use For the in vitro quantitative determination of cortisol in human serum, plasma, urine and saliva. Note: Serum and plasma cleared under K000270 and urine cleared under K021218. Indications for The determination of cortisol is used for the recognition and treatment of Use functional disorders of the adrenal gland.

{1}------------------------------------------------

## 510(k) Summary, Continued

| Substantial<br>equivalence | The Elecsys Cortisol Immunoassay is substantially equivalent to other<br>devices legally marketed in the United States. We claim equivalence to the<br>Salimetrics HS (high sensitivity) Salivary Cortisol Enzyme cleared under<br>K011323. Both products are intended for use in the quantitative<br>determination of cortisol in human saliva. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Substantial The following table compares the Roche Elecsys Cortisol Immunoassay with equivalence the predicate device. comparison

| Feature | Elecsys Cortisol Immunoassay | HS Salivary Cortisol Enzyme<br>(predicate) |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the in-vitro quantitative<br>determination of cortisol in<br>serum, plasma, urine and saliva. | For the in vitro quantitative<br>determination of cortisol in<br>saliva. |
| Indication for Use | The determination of cortisol is<br>used for the recognition and<br>treatment of functional disorders<br>of the adrenal gland. | Used to measure adrenal<br>cortical function and as a screen<br>for Cushing's and Addison's<br>disease. Saliva cortisol<br>accurately reflects the amount<br>of serum cortisol in the<br>circulation. |
| Assay Protocol | Electrochemiluminescent<br>Immunoassay | Competitive Solid Phase<br>Immunoassay |
| Traceability /<br>Standardization | Enzymun Test Cortisol, in turn<br>standardized via<br>ID-MS. | N/A |
| Calibration Interval | E170/E2010<br>After 1 month when using the<br>same reagent lot After 7 days when using the<br>same reagent kit E1010 With every reagent kit After 7 days (20-25°C) After 3 days (25-32°C) | N/A |
| Sample Type | Serum, plasma, urine & saliva | Saliva |

{2}------------------------------------------------

| Feature | Elecsys Cortisol Immunoassay | HS Salivary Cortisol Enzyme<br>(predicate) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Sample Collection<br>Method | Salivettes (Sarstedt) | Salivettes (Sarstedt) |
| Reagent Stability | Unopened at 2-8°C<br>• Up to stated expiration<br>Opened<br>• 12 weeks at 2-8°<br>• 8 weeks on E170/ 2010<br>• 2 weeks on E1010 (20-25°<br>ambient temp - up to 20<br>hours opened in total) | Stable at 2-8°C until kit<br>expiration date |
| Controls | Elecsys PreciControl Universal 1<br>and 2 | Cortisol Controls |
| Calibrator | Elecsys Cortisol CalSet | Cortisol Standards |
| Measuring Range | 1.00 - 1750 nmol/L<br>(0.036 - 63 ug/dL) | Calibrator range<br>0.007-1.800 ug/dl |
| Instrument | Elecsys family of analyzers<br>(Elecsys 1010, Elecsys 2010 and<br>Elecsys E170 MODULAR<br>Analytics Immunoassay<br>Analyzers) | Standard plate reader |

{3}------------------------------------------------

| Expected Values | | |
|-----------------|-----------------------------------------------------|-------------------------------------------------------------------------------|
| | Morning hours 8-10 AM:<br>1.90 – 19.1 nmol/L | Neonatal<br>0.010-3.606 ug/dl |
| | Afternoon hours 2:30-3:30 PM:<br>2.05 – 11.9 nmol/L | Age 6 months<br>0.010-2.890 ug/dl |
| | | Age 2.5-5.5 years<br>AM: 0.060-0.700 ug/dl<br>PM: 0.08-0.660 ug/dl |
| | | Age 8-11 years<br>AM: 0.112-0.904 ug/dl<br>PM: ND-0.249 ug/dl |
| | | Age 12-18 years<br>AM: 0.046-0.950 ug/dl<br>PM: ND-0.296 ug/dl |
| | | Age 21-30 years, males<br>AM: 0.112-0.743 ug/dl<br>PM: ND-0.308 ug/dl |
| | | Age 21-30 years, females<br>AM: 0.272-1.348 ug/dl<br>PM: ND-0.359 ug/dl |
| | | Age 31-50 years, males<br>AM: 0.122-1.551 ug/dl<br>PM: ND – 0.359 ug/dl |
| | | Age 31-50 years, females<br>AM: 0.094-1.515 ug/dl<br>PM: ND-0.181 ug/dl |
| | | Age 51-70 years, males<br>AM: 0.112-0.812 ug/dl<br>PM: ND - 0.228 ug/dl |
| | | Age 51-70 years, females<br>AM: 0.149-0.739 ug/dl<br>PM: 0.022-0.254 ug/dl |
| | | All Adults<br>AM: 0.094-1.551 ug/dl<br>PM: ND-0.359 ug/dl<br>ND=none detected |
| | | Normal 0.004-0.116 ug/dl |
| | | Cushing's 0.141-9.170 ug/dl |

.

{4}------------------------------------------------

## 510(k) Summary, Continued

The performance characteristics of the Elecsys Cortisol Immunoassay and the Substantial predicate device are compared in the table below. equivalence – performance characteristics

| Feature | Elecsys Cortisol Immunoassay | HS Salivary Cortisol Enzyme (predicate) |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Precision | E2010<br>Within-run<br>6.1% CV @ 0.170 ug/dL<br>2.7% CV @ 0.417 ug/dL<br>4.0% CV @ 0.547 ug/dL<br>1.5% CV @ 0.576 ug/dL<br>2.8% CV @ 0.718 ug/dL<br>Between Run<br>*37.1% CV @ 0.034 ug/dL<br>7.2% CV @ 0.280 ug/dL<br>6.2% CV @ 0.613 ug/dL<br>4.9% CV @ 1.25 ug/dL<br>4.1% CV @ 1.54 ug/dL<br>*sample concentration below functional claim of assay. | Intra-assay<br>4.25% CV @ 1.591 ug/dL<br>4.97% CV @ 0.702 ug/dL<br>5.73% CV @ 0.188 ug/dL<br>5.28% CV @ 0.115 ug/dL |
| Functional<br>Sensitivity | < 2.0 nmol/L (< 0.07 ug/dL ) | N/A |
| Analytical<br>sensitivity (LDL) | < 0.500 nmoL/L (< 0.018 ug/dL) | < 0.007ug/dL |
| Method<br>Comparison | Elecsys Cortisol vs. Salimetrics<br>326 samples (0.05-1.83 ug/dl)<br><br>Slope = 0.90 (95% CI 0.87-0.94)<br>Intercept= 1.71 (95% CI 1.47-1.96)<br>r= 0.942 | N/A |

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe.

NOV 2 4 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kay A. Taylor, MT (ASCP), RAC Regulatory Program Principal, Regulatory Affairs Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

k043175 Re:

Trade/Device Name: Elecsys Cortisol Regulation Number: 21 CFR 862.1205 Regulation Name: Coristol (hydrocortisone and hydroxycorticosterone) Test System Regulatory Class: Class II Product Code: NHG Dated: November 9, 2004 Received: November 16, 2004

Dear Ms. Taylor:

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).

{6}------------------------------------------------

#### Page 2 -

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/dsma/dsmamain.html.

Sincerely yours,

Sincerely yours,

Cornelius B. Parks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

### Indications for Use

K043175 510(k) Number (if known):

Device Name: Elecsys Cortisol

Indications For Use:

The Elecsys Cortisol is an immunoassay for the in-vitro quantitative determination of cortisol in serum, plasma, urine and saliva.

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.

Prescription Use
(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. Benar
Division Sign-Off

sion Sign-

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k043175

Page 1 of 1