ELECSYS CA 15-3 II CALCHECK 5

K122242 · Roche Diagnostics · JJX · Dec 5, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122242
• Device Name: ELECSYS CA 15-3 II CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys CA 15-3 II 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 15-3 II reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostics use only.

Device Story

Elecsys CA 15-3 II CalCheck 5 is a set of five lyophilized levels of CA 15-3 antigen in human/equine serum matrix; used for calibration verification and assay range verification of Elecsys CA 15-3 II reagent on Elecsys and cobas e immunoassay analyzers. Device is used in clinical laboratory settings by trained personnel. Users reconstitute lyophilized material with distilled/deionized water; analyzer processes samples to verify calibration curves and reportable ranges. Output provides verification of assay performance; assists clinicians in ensuring accuracy of patient CA 15-3 test results.

Clinical Evidence

No clinical data. Bench testing only. Value assignment performed on MODULAR ANALYTICS E170; stability verified via accelerated and real-time studies; dilution studies confirmed performance within assay measuring range.

Technological Characteristics

Lyophilized human/equine serum matrix containing CA 15-3 antigen. Five levels. Reconstituted with 1.0 mL distilled/deionized water. Compatible with Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, 601, and 602 analyzers. Stability: 18 months shelf-life at 2-8°C; 4 hours post-reconstitution at 20-25°C.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys CA 15-3 II reagent on Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use by clinical laboratory professionals.

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 CA 19-9 CalCheck 5 (k101365)

Submission Summary (Full Text)

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# 长122242

## 510(k) Summary

#### DEC 5 2012 -

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Road, P.O. Box 50416<br>Indianapolis, IN 46250-0416<br>317-521-3501 |
| | Contact Person: Edie Eads<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: July 24, 2012 |
| Device Name | Proprietary name: Elecsys CA 15-3 II CalCheck 5<br>Common name: CA 15-3 II CalCheck 5<br>Classification: 21 CFR 862.1660, Single (specified) analyte controls (assayed and unassayed)<br>Product Code: JJX |
| Predicate device | The Elecsys CA 15-3 II CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys CA 19-9 CalCheck 5 (K101365). |
| Device Description | The Elecsys CA 15-3 II CalCheck 5 is a lyophilized product consisting of CA 15-3 in equine serum matrix (Level 1) or human serum matrix (Levels 2-5). During manufacture, the analyte is spiked into the matrix at the desired concentration levels. |

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#### Intended use The Elecsys CA 15-3 II 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 15-3 II reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostics use only. :

| Comparison | The table below compares Elecsys CA 15-3 II CalCheck 5 with the predicate | |
|------------|---------------------------------------------------------------------------|--|
| Table | devices, Elecsys CA 19-9 CalCheck 5 (K101365), | |

| Characteristic | Elecsys CA 15-3 II CalCheck 5<br>(Candidate) | Elecsys CA 19-9<br>CalCheck 5 (K101365) | Elecsys CA 15-3 CalSet<br>(K001468) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys CA 15-3 II<br>CalCheck 5 is an assayed control<br>for use in calibration verification<br>and for use in the verification of<br>the assay range established by<br>the Elecsys CA 15-3 II reagent<br>on the indicated Elecsys and<br>cobas e immunoassay analyzers.<br>For in vitro diagnostics use only. | The Elecsys CA 19-9<br>CalCheck 5 is an assayed<br>control for the use in<br>calibration verification and<br>for use in the verification of<br>the assay range established<br>by the Elecsys CA 19-9<br>reagent on the indicated<br>Elecsys and cobas e<br>immunoassay analyzers. | Elecsys CA 15-3 CalSet is<br>used for calibrating the<br>quantitative Elecsys CA 15-3<br>assay on Elecsys 1010 or 2010<br>immunoassay systems. |
| Analyte | CA 15-3 | CA 19-9 | CA 15-3 |
| Matrix | Human serum, equine serum<br>(Level 1) | Human Serum | Human Serum |
| Levels | Five | Same | Two |
| Format | Lyophilized | Same | NA |
| 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, and then<br>mix gently by inversion. | Same | The calibrators are supplied<br>ready for use in bottles that are<br>compatible with the system.<br>The calibrators should only be<br>left on the analyzers during<br>calibration at 20-25°C. After<br>use, close the bottles as soon<br>as possible and store at 2-8°C.<br>Because of possible<br>evaporation effects, not more<br>than 5 calibration procedures<br>per bottle set should be<br>performed. |
| Stability | Unopened:<br>Store at 2-8°C until expiration<br>date<br>Opened:<br>20-25°C: 4 hours | Same | Unopened:<br>Same<br>Opened:<br>Twelve weeks at 2-8°C<br>On the analyzers:<br>Up to five hours in total |

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### 510(k) Summary, Continued

Performance The Elecsys CA 15-3 II CalCheck 5 was evaluated for value assignment and Characteristics stability. See the following sections for details. Value Value assignment testing was conducted and must pass pre-defined Assignment acceptance criteria. For each Elecsys CA 15-3 II CalCheck 5 lot manufactured, the CalChecks are run in duplicate on at least three E170 analyzer measuring cells. The assigned value of each CalCheck is defined as the median value obtained over at least 6 determinations (duplicate runs on at least 3 analyzer measuring cells) of the respective CalCheck. The target value for each CalCheck is the median value obtained over at least 6 determinations of the respective CalCheck. The assigned range is calculated as ±21% of the assigned value for levels 2 through 5, while level 1 is assigned as a value ≤ 2.5 U/mL. The % CV is 5% for levels 2 through 5. The label states that each laboratory should establish appropriate acceptance criteria when using this product for its intended use. To ensure the values assigned using the master platform are transferrable and valid for the other instrument platforms, the same value assignment procedure is performed on the Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602 analyzers. The assigned values obtained on the additional analyzers are compared to those obtained on the MODULAR ANALYTICES E170. The median value obtained on the four additional analyzers must be within 10% of the master platform assigned value (10% for between analyzer platform tolerances). After this acceptance criterion is met, the assigned values from the master platform are deemed valid for the MODULAR ANALYTICS E170, Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602 immunoassay analyzers. Stability Real-time and accelerated stability tests were conducted to establish the shelflife and open-vial claims. Open-Vial Stability After Reconstitution: Real-time testing was performed and the data support the package insert claim that reconstituted Elecsys CA 15-3 II CalCheck 5 is stable up to 4 hours at 20-25°C. Shelf-Life Stability: The accelerated stability testing performed at 35°C supports an initial shelf-life claim of 18 months at 2-8℃. Real-time testing at 2-8℃ is on-going to support a claim of 36 months.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

### Letter Date: December 5, 2012

Roche Diagnostics C/O Ms. Edie Eads Regulatory Affairs Consultant 9115 Hague Road Indianapolis, IN 46250-0416

Re: k122242

Trade/Device Name: Elecsys CA 15-3 II CalCheck 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: November 02, 2012 Received: November 05, 2012

Dear Ms. Eads:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Edie Eads

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Maria M. Chan

Maria M. Chan, Ph.D.

Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health (OIR)

Center for Devices and Radiological Health

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### Indication for Use

510(k) Number (if known): k122242

Device Name: Elecsys CA 15-3 II CalCheck 5

Indication for Use:

The Elecsys CA 15-3 II 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 15-3 II reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostics 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)

Maria M. Chow

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

510(k) K122242