ELECSYS HCG STAT CALCHECK 5

K093700 · Roche Diagnostics Corp. · JJX · Mar 4, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093700
• Device Name: ELECSYS HCG STAT CALCHECK 5
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys HCG STAT 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 STAT reagent on the indicated Elecs and cobas e immunoassay analyzers.

Device Story

Elecsys HCG STAT CalCheck 5 is a lyophilized, human serum-based control material containing HCG analyte at five specific target concentrations. Used in clinical laboratory settings to verify calibration and assay range of Elecsys HCG STAT reagent on Elecsys 2010, cobas e411, and cobas e601 analyzers. Product is reconstituted with distilled or deionized water by laboratory personnel. Output is a measured value compared against established target ranges to ensure analyzer performance. Benefits include ensuring accuracy and linearity of HCG testing within the clinical diagnostic workflow.

Clinical Evidence

No clinical data. Performance evaluation was limited to value assignment and reliance on stability studies previously cleared in K092168 due to identical formulation.

Technological Characteristics

Lyophilized human serum matrix; five-level concentration set. Analyte: HCG. Reconstitution: 1.0 mL distilled/deionized water. Stability: 2-8°C unopened; 4 hours at 20-25°C reconstituted. Analyzers: Elecsys 2010, cobas e411, cobas e601. Traceable to NIBSC 75/589.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys HCG STAT 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 HCG+β CalCheck 5 (K092168)

Submission Summary (Full Text)

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K093700

MAR - 4 2010

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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>317-521-3577<br><br>Contact Person: Kelly Colleen O'Maine Adams<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: November 30, 2009 | |
| Device Name | Proprietary name: Elecsys HCG STAT CalCheck 5<br>Common name: HCG STAT CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and<br>unassayed) | |
| Predicate<br>device | The Elecsys HCG STAT 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 HCG+β CalCheck 5<br>(K092168). | |
| Device<br>Description | The Elecsys HCG STAT 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 STAT CalCheck 5 is an assayed control for use in<br>calibration verification and for use in the verification of the assay range<br>estabalished by the Elecsys HCG STAT 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 HCG STAT CalCheck 5 with the predicate Comparison Table device, Elecsys HCG+B Calcheck 5 (K092168). .

| Characteristic | Elecsys HCG+β CalCheck 5<br>(K092168) | Elecsys HCG STAT CalCheck 5 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The Elecsys HCG STAT 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 STAT reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Levels | Five | Five |
| Format | Lyophilized | Lyophilized |
| 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 hrs | Same |
| Matrix | Human serum matrix | Same |

Performance Characteristics

The Elecsys HCG STAT CalCheck 5 was evaluated for value assignment. Because Elecsys HCG STAT CalCheck 5 formulation is identical to the Elecsys HCG+B CalCheck 5, the stability studies presented and cleared in the HCG+ ß CalCheck 5 submission, K092168, apply

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three parallel, curved lines.

Roche Diagnostics Corp c/o Kelly C. O'Maine Adams 9115 Hague Road PO Box 50410 Indianapolis, Indiana 46250-0416 Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

MAR 0 4 2010

k093700 Re:

> Trade Name: ELECYS HCG STAT CALCHECK 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Calibrator. Regulatory Class: Class I Product Codes: JJX Dated: February 8, 2010 Received: February 12, 2010

Dear Ms. 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 [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/Resourcesfor You/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

510(k) Number (if known):

i o937vr2

Device Name: Elecsys HCG STAT CalCheck 5

Indication For Use:

The Elecsys HCG STAT 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 STAT 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)

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

510(k) K 093700

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