ELECSYS N-MID OSTEOCALCIN CALCHECK 5

K112104 · Roche Diagnostics · JJX · Aug 25, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112104
• Device Name: ELECSYS N-MID OSTEOCALCIN CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys N-MID Osteocalcin 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 N-MID Osteocalcin reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use.

Device Story

Lyophilized human serum matrix spiked with osteocalcin; used to verify calibration and assay range of Elecsys N-MID Osteocalcin reagent on Elecsys/cobas e immunoassay analyzers. Reconstituted with distilled/deionized water by laboratory personnel. Provides five levels of target values; reagent lot-specific. Not for use as primary calibrator or control material.

Clinical Evidence

No clinical data. Performance was evaluated through bench testing, specifically focusing on value assignment and stability testing.

Technological Characteristics

Lyophilized human serum matrix; five-level concentration; reconstituted with 1.0 mL water. Analyte: Osteocalcin. Stability: 18 months at 2-8°C (unopened), 5 hours at 20-25°C (reconstituted). Traceable to in-house reference standard.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys N-MID Osteocalcin reagent on Elecsys and cobas e immunoassay analyzers. For prescription use.

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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K112114

| 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<br><br>Contact Person: Jane Phillips, PhD<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br><br>Secondary Contact: Kelly Colleen O'Maine Adams<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br><br>Date Prepared: July 15, 2011 | |
| Device Name | Proprietary name: Elecsys N-MID Osteocalcin CalCheck 5<br>Common name: Osteocalcin CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and<br>unassayed) | |
| Predicate<br>device | The Elecsys N-MID Osteocalcin CalCheck 5 is substantially equivalent to<br>other 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 N-MID Osteocalcin CalCheck 5 is a lyophilized product<br>consisting of synthetic osteocalcin in a human serum matrix. During<br>manufacture, the analyte is spiked into the matrix at the desired concentration<br>levels. | |
| Intended use | The Elecsys N-MID Osteocalcin 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 N-MID Osteocalcin reagent on the indicated<br>Elecsys and cobas e immunoassay analyzers. | |

Continued on next page

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## 510(k) Summary, Continued

## Comparison Table The table below compares Elecsys N-MID Osteocalcin CalCheck 5 with the predicate device, Elecsys DHEA-S CalCheck 5 (K103402).

| Characteristic | Elecsys N-MID Osteocalcin<br>CalCheck 5 (Candidate Device) | Elecsys DHEA-S CalCheck 5<br>(K103402) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | | |
| Intended Use | The Elecsys N-MID Osteocalcin<br>CalCheck 5 is an assayed control for<br>use in calibration verification and<br>for use in the verification of the<br>assay range established by the<br>Elecsys N-MID Osteocalcin reagent<br>on the indicated Elecsys and cobas e<br>immunoassay analyzers. | The Elecsys DHEA-S CalCheck 5 is<br>an assayed control for use in<br>calibration verification and for use in<br>the verification of the assay range<br>established by the Elecsys DHEA-S<br>reagent on the indicated Elecsys and<br>cobas e immunoassay analyzers. |
| Stability | Reconstituted:<br>• 20-25°C: 5 hours | Reconstituted:<br>• 20-25°C: 4 hours |
| Analyte | Osteocalcin | DHEA-S |
| Similarities | | |
| Levels | Five | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1, Check 2,<br>Check 3, Check 4, and Check 5 with<br>exactly 1.0 mL distilled or deionized<br>water. Allow to stand closed for 15<br>minutes, then mix gently by<br>inversion. | Same |
| Matrix | Human serum matrix | Same |
| Stability | Unopened:<br>• Store at 2-8°C until expiration<br>date | Unopened:<br>• Same |

## The Elecsys N-MID Osteocalcin CalCheck 5 was evaluated for value Performance Characteristics assignment and stability.

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

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Roche Diagnostics c/o Ms. Jane Ellen Phillips Program Manager, Regulatory Submissions 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250

> Re: k112104 Trade Name: Elecsys N-MID Osteocalcin CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved Product Codes: JJX Dated: July 21, 2011 Received: July 22, 2011

Dear Ms. Phillips,

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 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.

Courtney 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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## Indications for Use Form

510(k) Number (if known):

Device Name: Elecsys N-MID Osteocalcin CalCheck 5

Indications for Use:

The Elecsys N-MID Osteocalcin 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 N-MID Osteocalcin reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Prescription Use X (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 OF NEEDED)

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

Division Officer

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

510(k) k112104

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