ELECSYS CORTISOL CALCHECK

K000576 · Roche Diagnostics Corp. · JIX · Mar 21, 2000 · Clinical Chemistry

Device Facts

• Record ID: K000576
• Device Name: ELECSYS CORTISOL CALCHECK
• Applicant: Roche Diagnostics Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Mar 21, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Elecsys® Cortisol CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Cortisol assay.

Device Story

Elecsys® Cortisol CalCheck is a set of three lyophilized calibration verification solutions (low, mid, high) with defined cortisol concentrations. Used in clinical laboratories to verify the calibration of the Elecsys® Cortisol assay on Elecsys® Immunoassay Analyzers. The low solution is near the assay detection limit; the middle solution is near the lower measuring range; the high solution is near the upper measuring range. Laboratory personnel use these solutions to ensure assay accuracy and performance over the analytical range.

Clinical Evidence

Bench testing only. Evaluation focused on value assignment and stability of the calibration verification material.

Technological Characteristics

Lyophilized product; human serum base; synthetic cortisol; preservative. Three-level concentration set (low, mid, high). Designed for use with Elecsys Immunoassay Analyzers.

Indications for Use

Indicated for periodic calibration verification of the Elecsys® Cortisol assay. Intended for professional laboratory use.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Elecsys CalCheck TSH

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of human profiles facing right, suggesting a sense of community and care. The text is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 1, 2016

ROCHE DIAGNOSTICS CORP. KAY TAYLOR 9115 HAGUE RD. P.O. BOX 50457 INDIANAPOLIS IN 46250-0457

RE: K000576

Trade/Device Name: Elecsys Cortisol CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Code: JJX Dated: February 18, 2000 Received: February 22, 2000

Dear Ms. Taylor:

This letter corrects our substantially equivalent letter of March 21, 2000.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows the name "Katherine Serrano" in a large, bold font. Below the name, there is a large letter "S" on the left side. In the background, there is a faint, stylized logo that appears to be the FDA logo.

For :

Courtney H. Lias Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): NIA 40005 74

Device Name: Elecsys® Cortisol CalCheck

Indications For Use:

Elecsys® Cortisol CalCheck calibration verification solutions comprise three levels low, mid, and high - each with a defined Cortisol concentration. The low solution low, lind, and migh - caen with a stection limit of the assay. The middle solution is in the concentration is near the lower actooint of the measuring range. The high solution is near the upper limit of the measuring range.

The Elecsys® Cortisol CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Cortisol assay.

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Coogee

(Division Sign-Off)
Division of Clinical Labora
510(k) Number 4000576

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K000576

## 510(k) Summary

| 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 Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>(317) 576 - 3544<br><br>Contact Person: Kay A. Taylor<br><br>Date Prepared: February 18, 2000 |
| Device Name | Proprietary name: Elecsys® Cortisol CalCheck<br><br>Common name: Calibration Verification Material<br><br>Classification name: Single (specified) analyte controls (assayed + unassayed) |
| Predicate device | The Elecsys® Cortisol CalCheck is substantially equivalent to the currently marketed Elecsys CalCheck TSH. |
| Device Description | The Elecsys® Cortisol CalCheck is a lyophilized product manufactured using a human serum base, synthetic cortisol, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels. |

:

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## 510(k) Summary, Continued

| Intended use | The Elecsys® Cortisol CalCheck is used to verify the calibration of the<br>Elecsys® Cortisol assay. |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>predicate<br>device | The Elecsys® Cortisol CalCheck is substantially equivalent to other products<br>in commercial distribution intended for similar use. Most notably, it is<br>substantially equivalent to the currently marketed Elecsys® CalCheck™<br>TSH. |
| | Both products are intended to be used for the verification of calibration for<br>analytes on the Elecsys® Immunoassay Analyzers. |
| Performance<br>Characteristics | The Elecsys® Cortisol CalCheck was evaluated for value assignment and<br>stability. |