ELECSYS DHEA-S CALCHECK 5

K103402 · Roche Diagnostics · JJX · Jan 7, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103402
• Device Name: ELECSYS DHEA-S CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys DHEA-S CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys DHEA-S reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys DHEA-S CalCheck 5 is a lyophilized, human serum-based control product containing DHEA-S analyte. Used in clinical laboratory settings by technicians to perform calibration verification and verify the assay range of Elecsys DHEA-S reagents on Elecsys and cobas e immunoassay analyzers. The device is reconstituted with distilled or deionized water before use. By comparing measured values against established ranges, the device assists healthcare providers in ensuring the accuracy and reliability of patient DHEA-S test results, supporting clinical decision-making related to adrenal function and androgen status.

Clinical Evidence

No clinical data. Evaluation was limited to bench testing, specifically value assignment and stability studies.

Technological Characteristics

Lyophilized human serum matrix containing DHEA-S analyte. Reconstituted with 1.0 mL distilled or deionized water. Stability: 2-8°C unopened; 4 hours at 20-25°C after reconstitution. Five-level concentration format. Used on Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys DHEA-S reagent on Elecsys and cobas e immunoassay analyzers.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Elecsys C-Peptide CalCheck 5 (K100810)

Submission Summary (Full Text)

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## 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Road, P.O. Box 50416<br>Indianapolis, IN 46250-0416<br>317-521-3501 | |
| | Contact Person: Kelly Colleen O'Maine Adams<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| | Secondary Contact: Stephanie Greeman<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| | Date Prepared: December 28, 2010 | |
| Device Name | Proprietary name: Elecsys DHEA-S CalCheck 5<br>Common name: DHEA-S CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and<br>unassayed) | |
| Predicate<br>device | The Elecsys DHEA-S CalCheck 5 is substantially equivalent to other<br>products in commercial distribution intended for similar use. We claim<br>equivalency to the currently marketed Elecsys C-Peptide CalCheck 5<br>(K100810). | |
| Device<br>Description | The Elecsys DHEA-S CalCheck 5 is a lyophilized product consisting of<br>DHEA-S in a human serum matrix. During manufacture, the analyte is spiked<br>into the matrix at the desired concentration levels. | |
| Intended use | The Elecsys DHEA-S CalCheck 5 is an assayed control for use in calibration<br>verification and for use in the verification of the assay range established by<br>the Elecsys DHEA-S reagent on the indicated Elecsys and cobas e<br>immunoassay analyzers. | |

Continued on next page

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### - 510(k) Summary, Continued

The table below compares Elecsys DHEA-S CalCheck 5 with the predicate Comparison Table device, Elecsys C-Peptide CalCheck 5 (K100810).

| Characteristic | Elecsys C-Peptide CalCheck 5<br>(K100810) | Elecsys DHEA-S CalCheck 5<br>(Candidate Device) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys C-Peptide CalCheck 5 is an<br>assayed control for use in calibration<br>verification and for use in the verification<br>of the serum and plasma assay range<br>established by the Elecsys C-Peptide<br>reagent on the indicated Elecsys and cobas<br>e immunoassay analyzers. | The Elecsys DHEA-S CalCheck 5 is an<br>assayed control for use in calibration<br>verification and for use in the verification<br>of the assay range established by the<br>Elecsys DHEA-S reagent on the indicated<br>Elecsys and cobas e immunoassay<br>analyzers. |
| Analyte | C-Peptide | DHEA-S |
| Levels | Five | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1, Check 2, Check 3,<br>Check 4, and Check 5 with exactly 1.0 mL<br>distilled or deionized water. Allow to stand<br>closed for 15 minutes, then mix gently by<br>inversion. | Same |
| Stability | Unopened:<br>• Store at 2-8°C until expiration date<br>Reconstituted:<br>• 20-25°C: 4 hours | Unopened:<br>• Same<br>Reconstituted:<br>• Same |
| Matrix | Equine serum matrix | Human serum matrix |

Performance Characteristics

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The Elecsys DHEA-S CalCheck 5 was evaluated for value assignment and stability. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA."

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Roche Diagnostics

Roche Professional Diagnostics c/o Ms. Kelly Colleen O' Maine Adams Regulatory Affairs Consultant 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Jan 0 7 2011

Re: k103402 Trade Name: Elecsys DHEA-S CalCheck 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I reserved Product Codes: JJX Dated: November 18, 2010 Received: November 19, 2010

Dear Ms. O'Maine Adams:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301).796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

CA

Courtney C. Harper, Ph.D. 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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### Indication for Use

510(k) Number (if known):

K103402

JAN - 7 2011

Device Name: Elecsys DHEA-S CalCheck 5

Indication For Use:

The Elecsys DHEA-S CalCheck 5 is an assayed control for use in calibration verification
for the same of the and and and stablished by the Flective DHFA-S The Elecsys DHEA-S CalCheck J is an assay range established by the Elecsys DHEA-S
and for use in the verification of the assay range established by the Elecsys on buyers and for use in the vertricultion of the active immunoassay analyzers.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k/03402