ELECSYS HCG+B CALCHECK 5

K092168 · Roche Diagnostics · JJX · Nov 16, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092168
• Device Name: ELECSYS HCG+B CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys HCG+β 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 HCG+β reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys HCG+β CalCheck 5 is a lyophilized, assayed quality control material consisting of HCG in a human serum matrix; used in clinical laboratory settings to verify calibration and reportable range of Elecsys HCG+β reagent on Elecsys and cobas e immunoassay analyzers. Product is reconstituted with distilled or deionized water by laboratory personnel. Provides five concentration levels to ensure analytical performance across the assay range. Benefits patient care by ensuring accuracy and reliability of HCG immunoassay results used for diagnostic testing.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (real-time and accelerated) confirmed shelf-life and reconstituted stability. Value assignment performed using multiple Elecsys 2010/cobas e411 and MODULAR ANALYTICS E140/cobas e 601 analyzers, with target values determined as the median of duplicate measurements.

Technological Characteristics

Lyophilized human serum matrix; five concentration levels; reconstituted with distilled or deionized water; stored at 2-8°C unopened; stability 4 hours at 20-25°C after reconstitution. No electronic or software components.

Indications for Use

Indicated for use as an assayed control for calibration verification and reportable range verification of the Elecsys HCG+β reagent on Elecsys and cobas e immunoassay analyzers. No specific patient population or contraindications described.

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 HCG+β CalCheck (k010237)

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<br>Indianapolis, IN 46250<br>317-521-3952<br>NOV 1 6 2009<br><br>Contact Person: Sarah Baumann<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br><br>Secondary Contact: Stephanie Greeman<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br><br>Date Prepared: July 16, 2009 |
| Device Name | Proprietary name: Elecsys HCG+\$\beta\$ CalCheck 5<br>Common name: HCG+\$\beta\$ CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and<br>unassayed) |
| Predicate<br>device | The Elecsys HCG+\$\beta\$ CalCheck 5 is substantially equivalent to other products<br>in commercial distribution intended for similar use. We claim equivalency to<br>the currently marketed Elecsys HCG+\$\beta\$ CalCheck (K010237). |
| Device<br>Description | The Elecsys HCG+\$\beta\$ CalCheck 5 is a lyophilized product consisting of<br>HCG in human serum matrix. During manufacture, the analyte is spiked into<br>the matrix at the desired concentration levels. |
| Intended use | The Elecsys HCG+ \$\beta\$ CalCheck 5 is an assayed control for use in calibration<br>verification and for use in the verification of the reportable range established<br>by the Elecsys HCG+\$\beta\$ reagent on the indicated Elecsys and cobas e<br>immunoassay analyzers. |

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15092168

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## 510(k) Summary, Continued

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The table below compares Elecsys HCG+B CalCheck 5 with the predicate Comparison Table device, Elecsys HCG+β Calcheck (K010237).

| Characteristic | Elecsys HCG+β CalCheck<br>(K010237) | Elecsys HCG+β CalCheck 5 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the verification of the<br>calibration established by the<br>Elecsys HCG+β reagent on Elecsys<br>1010 or 2010 immunoassay<br>analyzers. | The Elecsys HCG+ β CalCheck 5 is<br>an assayed control for use in<br>calibration verification and for use<br>in the verification of the reportable<br>range established by the Elecsys<br>HCG+β reagent on the indicated<br>Elecsys and cobas e immunoassay<br>analyzers. |
| Levels | Three | Five |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1 and Check 2<br>with exactly 1.0 mL distilled or<br>deionized water. Reconstitute<br>Check 3 with exactly 1.5 mL<br>distilled or deionized water. Allow<br>to stand closed for 15 minutes, then<br>mix gently by inversion. | Reconstitute Check 1, Check 2,<br>Check 3, Check 4, and Check 5<br>with exactly 1.0 mL distilled or<br>deionized water. Allow to stand<br>closed for 15 minutes, then mix<br>gently by inversion. |
| Stability | Unopened:<br>Store at 2-8°C until expiration<br>date<br>Reconstituted:<br>20 – 25°C : 4 hrs | Same |
| Matrix | Human serum matrix | Same |

Performance Characteristics The Elecsys HCG+B CalCheck 5 was evaluated for value assignment and stability.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Roche Diagnostics c/o Ms. Sarah Baumann 9115 Hague Road, P.O. Box 50410 Indianapolis, IN 46250-0416

NOV 1 6 2009

Re: k092168

Trade/Device Name: Elecsys hCG+B CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: October 20, 2009 Received: October 21, 2009

Dear Ms. Baumann:

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 class II (Special Controls), 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

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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 [phone]. 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,

Signature

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

1092168 510(k) Number (if known):

Device Name: Elecsys HCG+B CalCheck 5

Indication For Use:

The Elecsys HCG+B 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 HCG+B 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 (OIVD)

Carol Benson

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

510(k) K092168