ELECSYS PROLACTIN II CALCHECK 5

K110613 · Roche Diagnostics · JJX · May 12, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110613
• Device Name: ELECSYS PROLACTIN II CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys Prolactin II 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 Prolactin II reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys Prolactin II CalCheck 5 is a lyophilized, equine serum-based control material containing prolactin at five target concentrations. Used in clinical laboratory settings on Elecsys and cobas e immunoassay analyzers to verify calibration and assay reportable ranges. The product is reconstituted with distilled or deionized water by laboratory technicians. It is not a primary calibrator or routine control. Value assignment is performed using master calibrators traceable to the 3rd IRP WHO 84/500 international standard, with values assigned via median testing on cobas e 601 analyzers and transferred to other compatible platforms. Healthcare providers use the resulting verification data to ensure the accuracy and linearity of the immunoassay system within the established reportable range.

Clinical Evidence

No clinical data. Bench testing only. Value assignment was validated using cobas e 601 analyzers, with transferability confirmed for Elecsys 2010 and cobas e 411 platforms. Stability testing (real-time and accelerated) confirmed shelf-life and reconstituted stability.

Technological Characteristics

Lyophilized equine serum matrix containing prolactin. Five-level concentration set. Reconstituted with 1.0 mL distilled/deionized water. Stable at 2-8°C unopened; 4 hours at 20-25°C reconstituted. Traceable to 3rd IRP WHO 84/500 international standard.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys Prolactin II reagent on Elecsys and cobas e immunoassay analyzers. Not intended as a primary calibrator or routine control material.

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 DHEA-S CalCheck 5 (k103402)

Submission Summary (Full Text)

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# 510(k) Summary

ﺎ،

| 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: March 2, 2011 |
| Device Name | Proprietary name: Elecsys Prolactin II CalCheck 5<br>Common name: Prolactin II CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and<br>unassayed) |
| Predicate<br>device | The Elecsys Prolactin II CalCheck 5 is substantially equivalent to other<br>products in commercial distribution intended for similar use. We claim<br>equivalency to the cleared Elecsys DHEA-S CalCheck 5 (K103402). |
| Device<br>Description | The Elecsys Prolactin II CalCheck 5 is a lyophilized product consisting of<br>prolactin in an equine serum matrix. During manufacture, the analyte is<br>spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys Prolactin II CalCheck 5 is an assayed control for use in<br>calibration verification and for use in the verification of the assay range<br>established by the Elecsys Prolactin II reagent on the indicated Elecsys and<br>cobas e immunoassay analyzers. |
| | Continued on next page |

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## 510(k) Summary, Continued

The table below compares Elecsys Prolactin II CalCheck 5 with the predicate Comparison Table device, Elecsys DHEA-S CalCheck 5 (K103402).

| Characteristic | Elecsys Prolactin II CalCheck 5 (Candidate Device) | Elecsys DHEA-S CalCheck 5 (K103402) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys Prolactin II 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 Prolactin II reagent on the indicated Elecsys and cobas e immunoassay analyzers. | 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. |
| Analyte | Prolactin | DHEA-S |
| Levels | Five | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1, Check 2, Check 3, Check 4, and Check 5 with exactly 1.0 mL distilled or deionized water. Allow to stand closed for 15 minutes, then mix gently by 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 The Elecsys Prolactin II CalCheck 5 was evaluated for value assignment and Characteristics stability.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's role in protecting and promoting the health and well-being of the nation.

Re:

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

MAY 1 2 2011

Roche Diagnostics Corp. c/o Ms. Kelly Colleen O'Maine Adams Regulatory Affairs Consultant 9115 Hague Road, Bldg. A Indianapolis, Indiana 46250-0416

> k110613 Trade Name: Elecsys Prolactin II Calcheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: I, reserved Product Codes: JJX Dated: March 02, 2011 Received: March 03, 2011

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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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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 [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courthey 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

KII0613 510(k) Number (if known):

Device Name: Elecsys Prolactin II CalCheck 5

Indication For Use:

The Elecsys Prolactin II 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 Prolactin II reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Prescription Use X (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 (OVD)

Ous

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

510(k) K-110613