ELECSYS CA 19-9 CALCHECK 5

K101365 · Roche Diagnostics Corp. · JJX · Oct 5, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101365
• Device Name: ELECSYS CA 19-9 CALCHECK 5
• Applicant: Roche Diagnostics Corp.
• 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 CA 19-9 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 CA 19-9 reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.

Device Story

Elecsys CA 19-9 CalCheck 5 is a lyophilized, assayed control product containing human CA 19-9 in a human serum matrix. It is used by laboratory professionals to verify the calibration and assay range of the Elecsys CA 19-9 reagent on Elecsys and cobas e immunoassay analyzers. The product is reconstituted with distilled or deionized water before use. By providing five specific concentration levels, it allows for the verification of the analytical measuring range, ensuring the accuracy and reliability of patient sample testing performed on the immunoassay analyzers. This verification process supports clinical decision-making by confirming that the analyzer is performing within established specifications.

Clinical Evidence

No clinical data. Performance evaluation was limited to bench testing, specifically focusing on value assignment and stability testing.

Technological Characteristics

Lyophilized human serum matrix containing CA 19-9 analyte. Five-level concentration set (≤ 3, 35, 500, 800, 1000 U/mL). Reconstitution required with 1.0 mL distilled/deionized water. Stability: 2-8°C unopened; 4 hours at 20-25°C after reconstitution. Designed for use on Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys CA 19-9 reagent on Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic 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 C-Peptide CalCheck 5 (K100810)
• CA 19-9 CalCheck (K051185)

Submission Summary (Full Text)

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K 101367

バ

| 510(k) Summary | OCT - |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| | 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: September 27, 2010 |
| Device Name | Proprietary name: Elecsys CA 19-9 CalCheck 5<br>Common name: CA 19-9 CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and<br>unassayed) |
| Predicate<br>device | The Elecsys CA 19-9 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 C-Peptide CalCheck 5 (K100810) and CA 19-<br>9 CalCheck (K051185). |
| Device<br>Description | The Elecsys CA 19-9 CalCheck 5 is a lyophilized product consisting of<br>human CA 19-9 in human serum matrix. During manufacture, the analyte is<br>spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys CA 19-9 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 CA 19-9 reagent on the indicated Elecsys and cobas e<br>immunoassay analyzers. For in vitro diagnostic use only. |

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## 510(k) Summary, Continued

Comparison The table below compares Elecsys CA 19-9 CalCheck 5 with the predicate Table devices, Elecsys C-Peptide CalCheck 5 (K100810) and CA 19-9 CalCheck (K051185). The first predicate shows that CA 19-9 CalCheck 5 is substantially equivalent to another CalCheck 5 product, Elecsys C-Peptide CalCheck 5. The Elecsys CA 19-9 CalCheck 5 is also substantially equivalent to the second predicate, CA 19-9 CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and one or both predicate devices.

| Characteristic | Elecsys C-Peptide<br>CalCheck 5 (K100810) | Elecsys CA 19-9<br>CalCheck 5<br>(Candidate Device) | Elecsys CA 19-9<br>CalCheck<br>(K051185) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys C-Peptide<br>CalCheck 5 is an assayed<br>control for use in calibration<br>verification and for use in<br>the verification of the serum<br>and plasma assay range<br>established by the Elecsys<br>C-Peptide reagent on the<br>indicated Elecsys and cobas<br>e immunoassay analyzers. | The Elecsys CA 19-9<br>Calcheck 5 is an assayed<br>control for use in<br>calibration verification and<br>for use in the verification<br>of the assay range<br>established by the Elecsys<br>CA 19-9 reagent on the<br>indicated Elecsys and<br>cobas e immunoassay<br>analyzers. For in vitro<br>diagnostic use only. | For use in the verification of<br>the calibration established by<br>the Elecsys CA 19-9 reagent<br>on the indicated Elecsys and<br>cobas e immunoassay<br>analyzers. |
| Analyte | C-Peptide | CA 19-9 | CA 19-9 |
| Levels | Five | Five | Three |
| Assay Measuring<br>Range | 0.1 - 40 ng/mL | 0.600 - 1000 U/mL | 0.600 - 1000 U/mL |
| Check Target<br>Values | Check 1: <0.2 ng/mL<br>Check 2: 5.0 ng/mL<br>Check 3: 20 ng/mL<br>Check 4: 30 ng/mL<br>Check 5: 40 ng/mL | Check 1: ≤ 3U/mL<br>Check 2: 35 U/mL<br>Check 3: 500 U/mL<br>Check 4: 800 U/mL<br>Check 5: 1000 U/mL | Check 1: < 5 U/mL<br>Check 2: 179 U/mL<br>Check 3: 676 U/mL |
| Format | Lyophilized | Lyophilized | Lyophilized |
| Handling | Reconstitute Check 1, Check<br>2. Check 3, Check 4, and<br>Check 5 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. | Reconstitute Check 1,<br>Check 2, Check 3, Check<br>4, and Check 5 with<br>exactly 1.0 mL distilled or<br>deionized water. Allow to<br>stand closed for 15<br>minutes, then mix gently<br>by inversion. | Reconstitute Check 1, Check<br>2, and Check 3 with exactly<br>1.0 mL distilled or deionized<br>water. Allow to stand closed<br>for 15 minutes, then mix<br>gently by inversion. |
| Stability | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• 20-25°C: 4 hours | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• 20-25°C: 4 hours | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• 20-25°C: 4 hours |
| Matrix | Equine serum matrix | Human serum matrix | Human serum matrix |

Continued on next page

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Performance Characteristics The Elecsys CA 19-9 CalCheck 5 was evaluated for value assignment and stability.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

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

Roche Diagnostics c/o Ms. Kelly Colleen O'Maine Adams, MTSC Regulatory Affairs Consultant 9115 Hague Road P.O.Box 50416 Indianapolis, IN, 46250-0416

OCT 0 5 2010

Re: k101365

Trade/Device Name: Elecsys CA 19-9 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: August 27, 2010 Received: August 31, 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 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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## Page 2 – Ms. Kelly Colleen O'Maine Adams

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/ReportalProblem/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,

for Maria M. Chan, Ph.D.

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

OCT - 5 2010

510(k) Number (if known): Ќю( 36 S

Device Name: Elecsys CA 19-9 CalCheck 5

Indication For Use:

The Elecsys CA 19-9 CalCheck 5 is an assayed control for use in callbration verification and for use in the verification of the assay range established by the Elecsys CA 19-9 reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.

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)

Reena Philip

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

510(k) k101365