ELECSYS CORTISOL TEST SYSTEM

K070788 · Roche Diagnostics · NHG · Oct 5, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070788
• Device Name: ELECSYS CORTISOL TEST SYSTEM
• Applicant: Roche Diagnostics
• Product Code: NHG · Clinical Chemistry
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1205
• Device Class: Class 2

Intended Use

Immunoassay for the in vitro quantitative determination of cortisol in human 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 Elecsys and cobas e immunoassay analyzers. Elecsys Cortisol CalSet is used for calibrating the quantitative Elecsys Cortisol assay on the Elecsys immunoassay analyzers.

Device Story

The Elecsys Cortisol Immunoassay is a quantitative, two-step sandwich immunoassay utilizing electrochemiluminescence (ECLIA) detection. It is designed for use on Elecsys and cobas e immunoassay analyzers. The system requires the use of a Salivette device for saliva sample collection. The assay operates by measuring cortisol levels in patient samples against a calibration curve generated by a 2-point calibration and a master curve provided via reagent bar code. The device is intended for clinical laboratory use to aid in diagnosing and managing adrenal gland functional disorders. Healthcare providers use the quantitative output to assess cortisol levels, which informs clinical decision-making regarding adrenal function. The system provides standardized, automated measurement of cortisol across multiple sample matrices.

Clinical Evidence

Bench testing only. Precision and sensitivity were evaluated using human saliva samples. The limit of quantitation (LoQ) was established at 8.5 nmol/L, defined as the concentration with a between-run coefficient of variation (CV) ≤ 20%. Precision studies demonstrated CVs ranging from 4.1% to 37.1% depending on concentration, with values below 8.5 nmol/L noted as unreliable. Reference ranges were established using saliva samples from 154 healthy individuals.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection; streptavidin microparticles. Analyzers: Elecsys 1010/2010, MODULAR ANALYTICS E170, cobas e 411/601. Measuring range: 1.00–1750 nmol/L. Calibration: 2-point calibration with master curve via reagent bar code. Standards: CLSI EP17-A (LoD/LoQ), CLSI EP5-A2 (Precision).

Indications for Use

Indicated for 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

• Elecsys Cortisol Assay (k043175)

Submission Summary (Full Text)

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KC70788

# 510(k) Summary - Elecsys Cortisol Test System

| 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 name, address, contact | Roche Diagnostics<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br>Contact person: Kay A. Taylor<br>Date prepared: September 13, 2007 |
| Device name | Proprietary name: Elecsys Cortisol Immunoassay<br>Elecsys Cortisol CalSet |
| | Common name: Cortisol test<br>Calibrator |
| | Classification name: Cortisol test system<br>Calibrator, Secondary |
| Device description | (1) The Elecsys Cortisol Assay is a two step competitive immunoassay with 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.<br>(2) The Elecsys Cortisol CalSet is a lyophilized product consisting of human serum with added cortisol (synthetic) in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. |

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## 510(k) Summary - Elecsys Cortisol Test System, Continued

| | Intended use | (1) Immunoassay for the in vitro quantitative determination of cortisol in<br>human serum, plasma, urine, and saliva. The determination of cortisol is used<br>for the recognition and treatment of functional disorders of the adrenal gland. |
|--|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | (2) Elecsys Cortisol CalSet is used for calibrating the quantitative Elecsys<br>Cortisol assay on the Elecsys immunoassay analyzers. |
| | Substantial<br>Equivalence | The Elecsys Cortisol Test System (modified) is substantially equivalent to<br>other devices legally marketed in the United States. The Elecsys Cortisol Test<br>System (modified) is equivalent to the Elecsys Cortisol Test System<br>(K043175). |
| | Device<br>Comparison | The following table compares the Elecsys Cortisol Test System (modified)<br>and the predicate device. The predicate labeling used as the source document<br>for the comparison is that provided to FDA in K043175. |

#### Comparison Table

| Feature | Predicate Device<br>Elecsys Cortisol Assay<br>(K043175) | Modified Device<br>Elecsys Cortisol<br>(K070788) |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent<br>Intended<br>Use/Indication<br>s for Use | Immunoassay for the in vitro<br>quantitative determination of cortisol<br>in human serum, plasma, urine, and<br>saliva. The determination of cortisol is<br>used for the recognition and treatment<br>of functional disorders of the adrenal<br>gland. | Same |
| Calibrator<br>Intended Use | Elecsys Cortisol CalSet is used for<br>calibrating the quantitative Elecsys<br>Cortisol assay on the Elecsys<br>immunoassay analyzers. | Same |
| Platform(s) | Elecsys 1010, Elecsys 2010, and<br>MODULAR ANALYTICS E170,<br>analyzers. | Elecsys 1010, Elecsys 2010, and<br>MODULAR ANALYTICS E170,<br>cobas e 411 and cobas e 601<br>analyzers. |
| Assay Protocol | Competitive assay | Same |
| Feature | Predicate Device<br>Elecsys Cortisol Assay<br>(K043175) | Modified Device<br>Elecsys Cortisol<br>(K070788) |
| Detection | Electrochemiluminescent | Same |
| Total Assay<br>Duration | 18 minute application | Same |
| Sample Type | Serum, plasma (Li, Na, NH4 Heparin,<br>K2, K3, Na2 EDTA and Na citrate),<br>saliva, urine | Same |
| Measuring<br>Range | 1.00- 1750 nmol/L or 0.036-63 µg/dL<br>(defined by the lower detection limit<br>and the maximum of the master curve).<br>Values below the detection limit are<br>reported as < 1.0 nmol/L (<0.036<br>µg/dL). Values above the measuring<br>range are reported as > 1750 nmol/L (><br>63 µg/dL) (or up to 17,500 nmol/L or<br>630 µg/dL for 10-fold diluted samples). | 1.00-1750 nmol/L or 0.036-63.0 µg/dL<br>(defined by the limit of detection and<br>the maximum of the master curve).<br>Values below the limit of blank are<br>reported as < 0.50 nmol/L (< 0.018<br>µg/dL). Values above the limit of<br>blank but below the limit of detection<br>will not be flagged by the instrument.<br>Values above the measuring range are<br>reported as > 1750 nmol/L (> 63.0<br>µg/dL) (or up to 17,500 nmol/L or 630<br>µg/dL for 10-fold diluted samples). |
| Sensitivity | < 0.500 nmol/L - Analytical (LDL)<br><2.0 nmol/L - Functional | ≤ 0.5 nmol/L - LoB<br>< 1.0 nmol/L - LoD<br>8.5 nmol/L - LoQ |
| Calibrator | Elecsys Cortisol Calset | Elecsys Cortisol CalSet |
| CalSet Levels | Two | Same |
| CalSet Matrix | Human serum w/ synthetic cortisol | Same |
| CalSet<br>Storage | Lyophilized | Same |
| CalSet Target<br>Conc. | Cal 1: ~12.5 nmol/L<br>Cal 2: ~1000 nmol/L | Same |
| Traceability /<br>Standardizati<br>on | Standardized against the Enzymun- Test<br>Cortisol method. This in turn was<br>standardized via ID-MS. | Same |
| Feature | Predicate Device<br>Elecsys Cortisol Assay<br>(K043175) | Modified Device<br>Elecsys Cortisol<br>(K070788) |
| Analytical<br>Specificity | For the monoclonal antibodies used,<br>the following cross-reactivities were<br>found: Osteocalcin, PTH fragment 1-<br>37, bone-specific alkaline phosphatase,<br>and β-Crosslaps: no cross-reactivity<br>detectable. | Same - reworded to be more clear<br><br>No cross-reactivities were found for:<br>Osteocalcin, PTH fragment 1-37,<br>bone-specific alkaline phosphatase,<br>and β-CrossLaps. |
| Limitations | Limitations remain unchanged from<br>K043175 | Same |
| Reagent<br>Stability | Unopened:<br>2-8°C - Up to the stated expiration<br>date<br><br>Opened:<br>2-8°C - 12 weeks<br>On the E170/ Elecsys 2010: 8 weeks<br>On the Elecsys 1010:<br>2 weeks (stored alternately in the<br>refrigerator and on the analyzer-<br>ambient temperature 20-25°C; up to 20<br>hours opened in total.) | Same - updated for inclusion of cobas<br>e analyzers only |
| Calibration<br>Interval | Calibration must be performed once<br>per reagent lot using fresh reagent (i.e.<br>not more than 24 hours since the<br>reagent kit was registered on the<br>analyzer).<br><br>Renewed calibration is recommended<br>as follows:<br>E170 and Elecsys 2010:<br>After 1 month (28 days) when using<br>the same reagent lot.<br>After 7 days (when using the same<br>reagent kit on the analyzer).<br>Elecsys 1010:<br>With every reagent kit.<br>After 7 days (20-25°C).<br>After 3 days (25-32°C). | Same - updated for inclusion of cobas<br>e analyzers only |
| Feature | Predicate Device<br>Elecsys Cortisol Assay<br>(K043175) | Modified Device<br>Elecsys Cortisol<br>(K070788) |
| Precision | Serum and urine precision data remain<br>unchanged from K043175 | |
| | <b>Saliva</b> | <b>Saliva</b> |
| | <b>Within-run</b> | <b>Within-run - SAME</b> |
| | 6.1% CV @ 4.68 nmol/L | |
| | 2.7% CV @ 11.5 nmol/L | |
| | 4.0% CV @ 15.1 nmol/L | |
| | 1.5% CV @ 15.9 nmol/L | |
| | 2.8% CV @ 19.8 nmol/L | |
| | <b>Between-run</b> | <b>Between-run</b> |
| | 37.1% CV @ 0.93 nmol/L | 33.4% CV @ 2.08 nmol/L |
| | 7.2% CV @ 7.72 nmol/L | 11.5% CV @ 8.05 nmol/L |
| | 6.2% CV @ 16.9 nmol/L | 7.1% CV @ 13.1 nmol/L |
| | 4.9% CV @ 34.6 nmol/L | 4.9% CV @ 34.6 nmol/L |
| | 4.1% CV @ 42.5 nmol/L | 4.1% CV @ 42.5 nmol/L |
| Expected<br>Values | Expected values for serum, plasma, urine remain unchanged from<br>K043175 | Same |
| | <b>Saliva:</b><br>The following values were determined<br>in saliva samples from 154 healthy<br>individuals (5th -95th percentile). | <b>Saliva:</b><br>The following values were determined<br>in saliva samples from 154 healthy<br>individuals (95th percentile). |
| | Morning hours 8-10 a.m:<br>1.90-19.1 nmol/L (0.07-0.69 µg/dl) | Morning hours 8-10 a.m:<br><19.1 nmol/L (<0.69 µg/dl) |
| | Afternoon hours 2:30-3:30 p.m.<br>2.05-11.9 nmol/L (0.07-0.43 µg/dl) | Afternoon hours 2:30-3:30 p.m.<br><11.9 nmol/L (<0.43 µg/dl) |

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## Premarket Notification 510(k): Device Modification -- Elecsys Cortisol Test System, Continued

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## Premarket Notification 510(k): Device Modification - Elecsys Cortisol Test System, Continued

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### Premarket Notification 510(k): Device Modification – Elecsys Cortisol Test System, Continued

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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 an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics, Inc. c/o Ms. Kay Taylor. Regulatory Affairs Principal 9115 Hague Road Indianapolis, IN 46250-0416

OCT 5 2007

Re: k070788

Trade/Device Name: Elecsys Cortisol Immunoassay & Elecsys Cortisol CalSet Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system. Regulatory Class: Class II Product Code: NHG, JIT Dated: September 05, 2007 Received: September 06, 2007

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).

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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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., 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): K070788

Device Name: Elecsys Cortisol Test System

Indications For Use:

#### Elecsys Cortisol Immunoassay

Immunoassay for the in vitro quantitative determination of cortisol in human 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 Elecsys and cobas e immunoassay analyzers.

#### Elecsys Cortisol CalSet

Elecsys Cortisol CalSet is used for calibrating the quantitative Elecsys Cortisol assay on the Elecsys immunoassay analyzers.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device

Evaluation and Safety

Page 1 of 1

Confidential

510(k)

K070788