ELECSYS CEA CALCHECK 5

K101856 · Roche Diagnostics · JJX · Oct 5, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101856
• Device Name: ELECSYS CEA CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys CEA 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 CEA CalCheck quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.

Device Story

Elecsys CEA CalCheck 5 is a set of 5 lyophilized human serum-based control levels containing CEA antigen. Used in clinical laboratories to verify calibration and assay range for Elecsys CEA quantitative assays on Elecsys and cobas e immunoassay analyzers. The device is reconstituted with distilled or deionized water by laboratory personnel. The healthcare provider compares the analyzer's measured values for these controls against target ranges to ensure system accuracy and reportable range performance. It is not intended as a primary calibrator or routine control material.

Clinical Evidence

No clinical data. Bench testing only. Performance was established by value assignment on MODULAR ANALYTICS E170 and Elecsys 2010 analyzers, demonstrating assigned values within 10% of targets. Stability was verified via accelerated and real-time studies.

Technological Characteristics

Lyophilized human serum matrix spiked with human CEA antigen. Five levels provided. Reconstituted with 1.0 mL distilled/deionized water. Analyte traceability to 1st IRP WHO Reference Standard 73/601. Compatible with MODULAR ANALYTICS E170, cobas e 601, Elecsys 2010, and cobas e 411 analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys CEA quantitative assay on specified Elecsys and cobas e immunoassay analyzers. Prescription use only.

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 CEA CalCheck (K970452)

Submission Summary (Full Text)

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| | OCT - 5 2010 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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: Jason Fisher<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: June 30, 2010 |
| Device Name | Proprietary name: Elecsys CEA CalCheck 5<br>Common name: CEA CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and<br>unassayed) |
| Predicate<br>device | The Elecsys CEA CalCheck 5 is substantially equivalent to other products in<br>commercial distribution intended for similar use. We claim equivalency to the<br>currently marketed Elecsys C-Peptide CalCheck 5 (K100810) and the Elecsys<br>CEA CalCheck (K970452). |
| Device<br>Description | The Elecsys CEA CalCheck 5 is a lyophilized product consisting of human<br>CEA in human serum matrix. During manufacture, the analyte is spiked into<br>the matrix at the desired concentration levels. |
| Intended use | The Elecsys CEA 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 CEA CalCheck quantitative assay reagent on the indicated<br>Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only. |

Continued on next page

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## 510(k) Summary, Continued

Comparison Table The table below compares Elecsys CEA CalCheck 5 with the predicate devices, Elecsys C-Peptide CalCheck 5 (K100810) and the CEA CalCheck (K970452).

> Please note that the use of two predicates has been utilized for this submission based on previous FDA feedback to several of the most recently FDA-cleared CalCheck 5 products. The first predicate shows that the CEA CalCheck 5 is substantially equivalent to another CalCheck 5 product. The Elecsys CEA CalCheck 5 is also substantially equivalent to the second predicate, CEA CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and a predicate device.

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| Characteristic | Elecsys C-Peptide<br>CalCheck 5 (K100810) | Elecsys CEA CalCheck 5<br>(Candidate Device) | Elecsys CEA CalCheck<br>(K970452) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys C-Peptide CalCheck<br>5 is an assayed control for use in<br>calibration verification and for<br>use in the verification of the<br>serum and plasma assay range<br>established by the Elecsys<br>C-Peptide reagent on the<br>indicated Elecsys and cobas e<br>immunoassay analyzers. | The Elecsys CEA Calcheck 5 is<br>an assayed control for use in<br>calibration verification and for<br>use in the verification of the<br>assay range established by the<br>Elecsys CEA reagent on the<br>indicated Elecsys and cobas e<br>immunoassay analyzers. | For use in the verification of the<br>calibration established by the<br>Elecsys CEA reagent on the<br>indicated Elecsys and cobas e<br>immunoassay analyzers. |
| Analyte | C-Peptide | CEA | CEA |
| Levels | Five | Five | Three |
| Format | Lyophilized | Same | Same |
| Handling | 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. | 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. | Reconstitute Check 1, Check 2,<br>and Check 3 with exactly 1.0 mL<br>distilled or deionized water.<br>Allow to stand closed for 15<br>minutes, then mix gently by<br>inversion. |
| Stability | Unopened:<br>• Store at 2-8°C until expiration<br>date<br>Reconstituted:<br>• 20-25°C: 4 hours | Unopened:<br>• Store at 2-8°C until expiration<br>date<br>Reconstituted:<br>• 20-25°C: 4 hours | Unopened:<br>• Store at 2-8°C until expiration<br>date<br>Reconstituted:<br>• 15-25°C: 4 hours |
| Matrix | Equine serum matrix | Human serum matrix | Human serum matrix |

Performance Characteristics

The Elecsys CEA CalCheck 5 was evaluated for value assignment and stability.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the bird.

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

Roche Diagnostics Roche Diagnostics Operations, Inc. c/o Mr. Jason D. Fisher Regulatory Affairs Principal 9115 Hague Road Indianapolis, IN, 46250-0457

OCT 05 2010

Re: k101856

Trade/Device Name: Elecsys CEA 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: September 7, 2010 Received: September 8, 2010

Dear Mr. Fisher:

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 of

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Page 2 - Mr. Jason D. Fisher

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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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,

Maria M. Chan, Ph.D.

Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indication for Use

KIDI856 OCT - 5 2010

510(k) Number (if known): K (Ol 856

Device Name: Elecsys CEA CalCheck 5

Indication For Use:

The Elecsys CEA 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 CEA CalCheck quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.

Prescription Usc __ 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)

Reena Philip

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

510(k) k 101856

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